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Drug Information Update July 2020

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TABLE OF CONTENTS NEWLY AVAILABLE GENERICS ................................................................. 2 NEW DRUG ENTITIES/STRENGTHS/COMBINATIONS ............................... 3 NEW INDICATIONS (EXISTING DRUGS) .................................................... 5 FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS .............................. 9 STUDIES AND RECENT TOPICS ............................................................... 19 RECALLS ................................................................................................ 26 CURRENT DRUG SHORTAGES ................................................................ 79


NEWLY AVAILABLE GENERICS

GENERIC DRUG NAME STRENGTH & DOSAGE FORM GENERIC

MANUFACTURER BRAND NAME

ORPHENADRINE/ ASPIRIN/CAFFEINE

50 mg-770 mg-60 mg TABLET GALT PHARMACEUTICALS NORGESIC FORTE


NEW DRUG ENTITIES/STRENGTHS/COMBINATIONS

DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES

METASTATIC SMALL CELL LUNG CANCER

(SCLC) ZEPZELCA LURBINECTEDIN 4 MG VIAL NEW ENTITY

NEUROMYELITIS OPTICA SPECTRUM

DISORDER (NMOSD) UPLINZA INDEBILIZUMAB-CDON

100 MG/10 ML VIAL NEW ENTITY

HUMAN SMALLPOX DISEASE TPOXX TECOVIRIMAT 200 MG CAPSULES NEW ENTITY

HER2-POSITIVE BREAST CANCER PHESGO

PERTUZUMAB, TRASTUZAM &

HYALURONIDASE-ZZXF

INJECTION 1,200 MG-600 MG-

30,000 UNITS AND 600 MG-600 MG-

20,000 UNITS SINGLE DOSE

VIALS

NEW ENTITY

ACUTE BACTERIAL SKIN & SKIN STRUCTURE

INFECTIONS (ABSSSI)

SIVEXTRO TEDIZOLID PHOSPHATE

FOR INJECTION, 200 MG;

200 MG TABLET

NEW PEDIATRIC PATIENT POPULATION

CONTRACEPTIVES,TRANSDERMAL TWIRLA

LEVONORGESTREL/ETHIN.

ESTRADIOL

120 MCG-30 MCG/24 HR.

TRANSDERMAL PATCH

NEW DOSAGE FORM, ROUTE, AND STRENGTH

SOMATOSTATIC AGENTS BYNFEZIA

OCTREOTIDE ACETATE

2,500 MCG/ML PEN INJECTOR

NEW DOSAGE FORM AND STRENGTH

DRAVET SYNDROME FINTEPLA FENFLURAMINE 2.2 MG/ML ORAL SOLUTION NEW ENTITY

HIV-1 RUKOBIA FOSTEMSAVIR 600 MG

EXTENDED-RELEASE TABLETS

NEW ENTITY


DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES

INFLUENZA VACCINES

FLUARIX, FLUZONE, FLUZONE

HIGH-DOSE, FLUBLOK, FLARIX,

AFLURIA, FLULAVAL,

FLUAD, FLUCELVAX

INFLUENZA VACCINE 1920-

1921 INJECTION NEW ENTITIES

MEDIUM-CHAIN TRIGLYCERIDE DOJOLVI TRIHEPTANOIN

8.3 KCAL/ML ORAL LIQUID

NEW ENTITY

PULMONARY MULTI-DRUG RESISTANT

TUBERCULOSIS (MDR-TB)

SIRTURO BEDAQUILINE 20 MG, 200 MG TABLETS NEW STRENGTH,

PEDIATRIC POPULATION

INFLUENZA VACCINES FLUMIST

QUADRIVALENT

INFLUENZA VACCINE, LIVE,

2020-2021

0.2 ML IN SINGLE DOSE

INTRANASAL SPRAYER

SUSPENSION

NEW ENTITY


NEW INDICATIONS (EXISTING DRUGS)

GARDASIL®9

June 12, 2020

Kenilworth, New Jersey-- Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for GARDASIL9 for the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58. The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The trial is currently underway. Source: Merck

TIVICAY®

June 12, 2020

London, England-- ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Tivicay PD (dolutegravir) tablets for oral suspension, which are used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric patients (treatment-naïve or -experienced but INSTI- naïve) aged at least four weeks and weighing at least 3kg, as well as an extended indication to expand the use of the already approved Tivicay (dolutegravir) 50mg film-coated tablet in pediatric HIV patients weighing 20kg and above.2 Source: ViiV Healthcare

COSENTYX®

June 16, 2020

East Hanover, New Jersey-- Novartis, a leader in rheumatology and immunodermatology, today announced that the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA), confirming Cosentyx efficacy in addressing the axial spondyloarthritis (axSpA) disease spectrum9. Source: Novartis

KEYTRUDA®

June 17, 2020

Kenilworth, New Jersey-- Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory


alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. Source: Merck

CRYSVITA®

June 18, 2020

Novato, California and Tokyo, Japan-- Ultragenyx Pharmaceutical Inc., a biopharmaceutical company focused on the development and commercialization of novel products for rare and ultra-rare diseases, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company creating innovative medical solutions using the latest biotechnology, today announced that the U.S. Food and Drug Administration (FDA) has approved Crysvita® (burosumab) for the treatment of fibroblast growth factor 23 (FGF23)-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adults and pediatric patients 2 years of age and older. Crysvita is a human antibody that blocks excess activity of FGF23, a hormone that causes phosphate urinary excretion and suppresses active vitamin D production by the kidney. Source: Ultragenyx Pharmaceutical Inc.

TAZVERIK™

June 18, 2020

Cambridge, Massachusetts-- Epizyme, Inc., a fully integrated, commercial-stage biopharmaceutical company developing novel epigenetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for TAZVERIK™ (tazemetostat) for the following two distinct follicular lymphoma (FL) indications: • Adult patients with relapsed or refractory FL whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies. • Adult patients with relapsed or refractory FL who have no satisfactory alternative treatment options. Source: Epizyme, Inc.

XPOVIO®

June 22, 2020

Newton, Massachusetts-- Karyopharm Therapeutics Inc. announced XPOVIO, nuclear export inhibitor indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. Source: Karyopharm Therapeutics Inc.


LIALDA®

June 26, 2020

Lexington, Massachusetts-- Shire US Inc. announced Lialda which is an aminosalicylate indicted for the treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. Source: Shire US Inc.

BENEFIX®

June 26, 2020

Philadelphia, Pennsylvania-- Wyeth BioPharma announced BeneFIX which is a recombinant human blood coagulation factor IX indicated for adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for routine prophylaxis to reduce the frequency of bleeding episodes. Source: Wyeth BioPharma LLC.

BAVENCIO®

June 30, 2020

Rockland, Massachusetts-- EMD Serono Inc. announced Bavencio is a programmed death ligand-1 (PD-L1) blocking antibody indicated for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. Source: EMD Serono Inc.

BOTOX®

July 9, 2020

NORTH CHICAGO, Ill.,-- Allergan, an AbbVie (NYSE: ABBV) company, today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental Biologics License Application (sBLA) that supports expanded use of BOTOX® for the treatment of spasticity in pediatric patients 2 years of age and older, including those with lower limb spasticity caused by cerebral palsy. Source: Allergan, an AbbVie Company

DYSPORT®

July 9, 2020

Cambridge, Mass.,-- Ipsen Biopharmaceuticals, an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY), announced today that the United States Food and Drug Administration (FDA) has approved the expanded use of Dysport® (abobotulinumtoxinA) in pediatric patients. When Dysport was first FDAapproved in 2016 for pediatric lower limb spasticity, Ipsen was granted Orphan Drug exclusivity for pediatric patients whose lower limb spasticity was caused by cerebral palsy (CP). Similarly, in 2019, Dysport received FDA approval for the treatment of upper limb spasticity in children two years of age


and older, excluding upper limb spasticity caused by CP, due to Orphan Drug exclusivity granted to another manufacturer. Ipsen has worked with the FDA and this manufacturer to selectively waive their respective exclusivities to better support patient care. As a result, Dysport is now FDA-approved to treat both upper and lower limb spasticity in pediatric patients two years of age and older, including spasticity caused by cerebral palsy. Source: Ipsen Biopharmaceuticals

TREMFYA®

July 17, 2020

Horsham, PA-- Janssen Biotech, Inc. announced Tremfya which is an interleukin-23 blocker indicated for the treatment of adult patients with active psoriatic arthritis. Source: Janssen Biotech, Inc.

QUTENZA®

July 21, 2020

Aachen, Germany & Morristown, N.J. 2020-- Grünenthal announced today that its U.S. subsidiary Averitas Pharma, Inc. received U.S. Food and Drug Administration (FDA) approval for QUTENZA® (capsaicin) 8% patch for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults. QUTENZA® is a topical, non-systemic, non-opioid pain treatment delivered in the form of a patch and is the first and only treatment of its kind to deliver prescription strength capsaicin directly into the skin. Source: Averitas Pharma


FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS

Remdesivir by Gilead Sciences: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of Treatment

[Posted June 15, 2020]

Today, the U.S. Food and Drug Administration is warning health care providers about a newly discovered potential drug interaction related to the investigational antiviral drug remdesivir, which has received emergency use authorization for the treatment of hospitalized COVID-19 patients with severe disease.

Based on a recently completed non-clinical laboratory study, the FDA is revising the fact sheet for health care providers that accompanies the drug to state that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. The agency is not aware of instances of this reduced activity occurring in the clinical setting but is continuing to evaluate all data related to remdesivir.

In addition, the FDA revised the fact sheet for health care providers to clarify dosing and administration recommendations and to provide additional safety data and supporting data from clinical trials conducted by both the National Institutes of Health and the drug sponsor, Gilead Sciences Inc. The fact sheet for patients and caregivers was also updated to include additional information about possible allergic reactions and to alert patients to tell their healthcare providers if they are taking chloroquine phosphate or hydroxychloroquine sulfate.

“Over the course of this unprecedented pandemic, the FDA has issued emergency use authorizations for a variety of medical products after evaluating the available scientific evidence and carefully balancing any known or potential risks against the benefits of making these products available during the current public health emergency. We understand that, as we learn more about these products, changes may be necessary based on new data – such as today’s updates for health care providers about a potential drug interaction and other important information about using remdesivir to treat COVID-19 patients,” said Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research. “As we have done throughout the pandemic, the FDA continues to evaluate all of the emergency use authorizations issued and their related materials and will continue to make changes as appropriate based on emerging science and data.”

Following an evaluation of the emergency use authorization criteria and the scientific evidence available, the FDA issued an emergency use authorization (EUA) in May 2020 allowing for remdesivir to be distributed in the U.S. and to be administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in adults and pediatric patients hospitalized with severe disease. The safety and efficacy of remdesivir for the treatment of COVID-19 continue to be evaluated, and preliminary clinical trial results have shown that on average, patients treated with remdesivir had more rapid time to recovery.

The EUA requires that fact sheets about using remdesivir in treating COVID-19 be made available to healthcare providers and to patients and caregivers. These fact sheets include information on possible side effects such as: increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and allergic reactions, which may include low blood pressure, high heart rate, low


heart rate, shortness of breath, wheezing, angioedema (for example, lip or tongue swelling), difficulty swallowing, rash, nausea, vomiting, sweating, shivering and respiratory distress.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: U.S. Food and Drug Administration (FDA)

GSK Consumer Healthcare Issues Voluntary Nationwide Recall of Children's Robitussin® Honey Cough and Chest Congestion DM and Children's Dimetapp® Cold and Cough Due to Dosing Cups Missing Some Graduation Markings

[Posted June 18, 2020]

GSK Consumer Healthcare is voluntarily recalling to the retail level two lots (listed below) of Children's Robitussin® Honey Cough and Chest Congestion DM and one lot of Children's Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups. During the review of the packaging documents for these products, GSK discovered that the dosing cups for the Children's Robitussin® Honey product are missing the 5 mL and 10 mL graduations, while the dosing cups for the Children's Dimetapp® product are missing the 10 mL graduation. The dosing cups packaged with both products only have the 20 mL graduation.

There is a potential risk of accidental overdose if caregivers dispensing the syrup do not notice the discrepancies between the graduations printed on the dosing cups and the indicated amounts to be administered (as directed in the instructions for use). Children's Robitussin Honey Cough & Chest Congestion DM contains 10 mg dextromethorphan HBr USP and guaifenesin USP 100 mg per 10 mL, and is labeled for children 4 and older, as well as adults. Children's Dimetapp Cold & Cough contains 2 mg brompheniramine maleate USP, 10 mg dextromethorphan HBr USP, and 5 mg phenylephrine HCl USP per 10 mL, and is labeled for children 6 and older, as well as adults. Symptoms of overdose of either product may include any of the following: impaired coordination; brain stimulation causing increase in energy, elevation in blood pressure, heart rate, and respiration; a lack of energy and enthusiasm; severe dizziness or drowsiness; slow heart rate; fainting; psychotic behavior; restlessness; seizure; decreased respiration; nausea; vomiting; constipation; diarrhea; abdominal pain; visual and hearing hallucinations; urinary retention. As of the date of the recall announcement, GSK Consumer Healthcare has not received any adverse events related to these products or consumer complaints regarding the incorrect dosing cups supplied with the product.

The recall is limited to the three lots listed below: Children's Robitussin® Honey Cough and Chest Congestion DM (4oz)

Lots: 02177 (Exp. Jan. 2022) 02178 (Exp. Jan. 2022)

Children's Dimetapp® Cold and Cough (8oz) NDC 0031-2234-19 Lot: CL8292 (Exp. Sep. 2021) These lots were distributed nationwide between February 5, 2020 and June 3, 2020 within the United States. GSK Consumer Healthcare has notified wholesalers, distributors and retailers to arrange for return of any


recalled product. Wholesalers, distributors and retailers with an existing inventory of the lots being recalled should stop distribution and quarantine these lots immediately. Wholesalers, distributors and retailers that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them.

Consumers with questions regarding this recall or to report an adverse experience please call 1-800-762-4675, Monday – Friday, 8:00am – 6:00pm EST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda

• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting


Granules Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

[Posted July 6, 2020]

Granules Pharmaceuticals, Inc., Chantilly, VA is voluntarily recalling twelve (12) lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 and 500 count bottles within expiry to the consumer level due to the detection of NNitrosodimethylamine (NDMA) levels above the Acceptable Daily Intake Limit.

Granules’ test results showed NDMA levels above the FDA acceptable limit in one (1) out of the twelve (12) batches distributed to the US market. All other batches continue to remain within the specifications. Out of abundance of caution Granules Pharmaceuticals, Inc. has decided to voluntarily recall all twelve (12) of the distributed lots within expiry of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg from the market.

Granules Pharmaceuticals, Inc. has not received any reports of adverse events that have been confirmed to be directly related to this recall as of the date of this letter.

Granules Metformin Hydrochloride Immediate-Release Tablets USP, 500 mg, 850 mg & 1000 mg and Metformin Hydrochloride Extended-Release Tablets USP, 500 mg are not affected by this recall.

https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fdahttps://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fdahttps://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reportinghttps://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting


Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Metformin Hydrochloride Extended-Release Tablets USP, 750 mg are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. The Metformin Hydrochloride Extended-Release Tablets USP, 750 mg lots subject to the recall is identified in the table below.

Metformin Hydrochloride Extended-Release Tablets USP, 750 mg

NDC Bottle Count Lot/Expiration

70010-492-01 100 count bottles 4920003A/May-21 4920004A/Jun-21 4920005A/Jun-21 4920009A/Nov-21 4920010A/May-22 4920011A/Jun-22 4920012A/Jun-22 4920013A/Jul-22 4920014A/Jul-22 4920015A/Aug-22 4920016A/Jan-23

70010-492-05 500 count bottles 4920005B/Jun-21

The affected Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, lots were distributed nationwide in the USA directly to Distributors, and Retailers. Granules Pharmaceuticals, Inc. is in the process of notifying its distributers and customers affected by this recall via mail (FedEx standard overnight) by mailing a recall notification letter and is arranging for return of the entire recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately.

Customers and patients with questions regarding this recall or wishing to return product may contact Inmar Pharmaceutical Services product recall processor to obtain instructions and a return kit for returning their medication:

• Contact Inmar at 888-985-9117 (Hours of Operation: 9 am to 5 pm Eastern Time, Monday – Friday) or email Inmar at: [email protected]

• Inmar will provide the materials needed to return their medication and instructions for reimbursement.

If you would like to report any adverse reactions or quality problems experienced with the use of this product you may contact Granules Drug Safety by phone at 1-877-7703183 Monday - Friday, 8:00 am EST to 8:00 pm EST, or via e-mail at [email protected].

mailto:[email protected]



• Complete and submit the report Online • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then

complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


Mylan Initiates Voluntary Nationwide Recall of One Lot of Daptomycin for Injection, Due to The Presence of Particulate


Mylan N.V.External Link Disclaimer (NASDAQ: MYL) today announced that its U.S.-based Mylan Institutional LLC business is conducting a voluntary nationwide recall to the consumer level of one lot of Daptomycin for Injection, 500 mg/vial due to the presence of particulate matter found in one single-dose vial manufactured by Mylan Laboratories Limited’s Specialty Formulation Facility. To date, Mylan has not received any reports of adverse events related to this recall.

Intravenous administration of a solution containing visible particulates could lead to serious adverse events including, but not limited to, local irritation, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism.

This batch was distributed nationwide to wholesalers and retail pharmacies between April 2020 and May 2020. The recalled batch is as follows:

NDC# Material Description

Strength Size Lot No. Expiry

67457-813-50

Daptomycin for Injection

500 mg/vial 20 mL vial 7605112 October 2021

Daptomycin for injection is an injectable antibacterial indicated for the treatment of complicated skin and skin structure infections (cSSSI) and staphylococcus aureus bloodstream infections (bacteremia) in adult patients.

Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop use/further distribution or dispensing. Wholesalers, retailers and consumers that are in possession of recalled product should contact Stericycle at 1-888-641-9736 for the return of the recalled product. Normal business hours are Monday through Friday 8 a.m. to 5 p.m. EST.

Consumers with questions regarding this recall can contact Mylan Customer Relations at 800.796.9526 or [email protected], Monday through Friday from 8 a.m. – 5 p.m. EST. Consumers should


contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.





Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, 500mg and 1000mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

[Update July 8, 2020]

Lupin Pharmaceuticals Inc. is voluntarily recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg to the consumer level. As part of the ongoing assessment and continuation of the dialog with the FDA, additional analysis revealed that certain tested batches were above the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA). Out of an abundance of caution, the company is recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg in the US. To date, Lupin Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.

Metformin Hydrochloride Extended-Release Tablets USP is a prescription oral medication indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg is packaged in 60, 90 and 100 count bottles and was distributed nationwide in the US to wholesalers, distributors, drug chain, mail order pharmacies and supermarkets. The recalled NDC’s are included in the table below:

Product Strengths NDC Distribution Dates

Metformin Hydrochloride Extended-Release Tablets USP

500 mg 68180-338-01 11/21/2018-05/27/2020


1000 mg 68180-339-09 11/21/2018-05/27/2020



500 mg 68180-336-07 11/05/2018-05/22/2020


1000 mg 68180-337-07 11/05/2018-05/22/2020

Lupin Pharmaceuticals Inc. is notifying its wholesalers, distributors, drug chain, mail order pharmacies and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product NDC’s.

Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 1000mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the U.S. Food & Drug Administration, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals. Please visit the agency’s website for more information at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin.

Wholesalers, distributors, and retailers that have Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg that are being recalled should discontinue distribution of the recalled product NDC’s immediately and return it to Inmar Rx Solutions, Inc., 635 Vine St, Winston Salem, NC 27101. Tel: (855) 532-1856.

Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (855) 532-1856 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled NDC’s returned to Inmar Rx Solutions, Inc.; the NDC number can be found on the top of the bottle label.





Fresenius Kabi Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine



Company Announcement

Fresenius Kabi USA is voluntarily recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg / mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to the possibility of a trace amount of lidocaine present in these two lots and our investigation indicates that this issue is limited to these two product lots. This recall is being performed to the user level.

To date, no adverse drug experience reports have been received for either of the lots being recalled by Fresenius Kabi. Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy, however, could result in anaphylaxis, a potentially life-threatening condition.

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is approved for intravenous use and indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. Listed below is a table of the recalled lots distributed nationwide to wholesalers, distributors, hospitals, and pharmacies between June 3, 2019 and April 8, 2020, as well as a copy of the label:

Product Name/Product

size

NDC Number

Product Code

Batch Number

Expiration Date

First Ship Date

Last Ship Date

Dexmedetomidine HCl in 0.9%

Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg /

mL), 50 mL fill in a 50 mL vial

63323-671-50 671050

6121853 05/2021 06/03/2019 12/04/2019

6122207 06/2021 03/12/2020 04/08/2020

Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product.

Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi. The recall letter and response form are available at https://www.fresenius- kabi.com/us/pharmaceutical-product-updatesExternal Link Disclaimer.

Customers with questions regarding this recall may contact Fresenius Kabi at 1-866-716- 2459 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Time. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.


• Complete and submit the report Online


• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

• Or, contact Fresenius Kabi at 1-800-551-7176, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Time or via email at: [email protected] or [email protected]


Opioid Pain Relievers or Medicines to Treat Opioid Use Disorder: MedWatch Safety Alert - FDA Recommends Health Care Professionals Discuss Naloxone with All Patients when Prescribing


TOPIC: Opioid Pain Relievers or Medicines to Treat Opioid Use Disorder: MedWatch Safety Alert - FDA Recommends Health Care Professionals Discuss Naloxone with All Patients when Prescribing ISSUE: FDA is requiring drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder (OUD) to add new recommendations about naloxone to the prescribing information. This will help ensure that health care professionals discuss the availability of naloxone and assess each patient’s need for a naloxone prescription when opioid pain relievers or medicines to treat OUD are being prescribed or renewed. The patient Medication Guides will also be updated.

BACKGROUND: Opioid pain relievers are medicines that can help manage pain when other treatments and medicines are not able to provide enough pain relief. Certain opioids are also used to treat OUD. Opioids have serious risks, including misuse and abuse, addiction, overdose, and death. Naloxone can help reverse opioid overdose to prevent death.

The misuse and abuse of illicit and prescription opioids and the risks of addiction, overdose, and death are a public health crisis in the United States. As a result, FDA is committed to encouraging health care professionals to raise awareness of the availability of naloxone when they are prescribing and dispensing opioid pain relievers or medicines to treat OUD. FDA held discussions about naloxone availability with the Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees, which recommended that all patients being prescribed opioids for use in the outpatient setting would benefit from a conversation with their health care professional about the availability of naloxone.

RECOMMENDATION:

Patients:

• Talk to your health care professionals about the benefits of naloxone and how to obtain it. • Recognize the signs and symptoms of a possible opioid overdose. These include slowed, shallow,

or difficult breathing, severe sleepiness, or not being able to respond or wake up. If you know or think someone is overdosing, give the person naloxone if you have access to it, and always call 911 or go to an emergency room right away. Naloxone is a temporary treatment, so repeat doses may be required. Even if you give naloxone, you still need to get emergency medical help right away.


• If you have naloxone, make sure to tell your caregivers, household members, and other close contacts that you have it, where it is stored, and how to properly use it in the event of an overdose. When using opioid medicines away from home, carry naloxone with you and let those you are with know you have it, where it is, and how to use it. Read the Patient Information leaflet or other educational material and Instructions for Use that comes with your naloxone because it explains important information, including how to use the medicine.

Health Care Professionals:

• Discuss the availability of naloxone with all patients when prescribing or renewing an opioid analgesic or medicine to treat OUD.

• Consider prescribing naloxone to patients prescribed medicines to treat OUD and patients prescribed opioid analgesics who are at increased risk of opioid overdose.

• Consider prescribing naloxone when a patient has household members, including children, or other close contacts at risk for accidental ingestion or opioid overdose.

• Additionally, even if the patients are not receiving a prescription for an opioid analgesic or medicine to treat OUD, consider prescribing naloxone to them if they are at increased risk of opioid overdose.

• Educate patients and caregivers on how to recognize respiratory depression and how to administer naloxone. Inform them about their options for obtaining naloxone as permitted by their individual state dispensing and prescribing requirements or guidelines for naloxone. Emphasize the importance of calling 911 or getting emergency medical help right away, even if naloxone is administered.

Patients and health care professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online. • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to

the address on the form, or submit by fax to 1-800-FDA-0178



STUDIES AND RECENT TOPICS

AstraZeneca blood cancer drug shows signs of helping COVID-19 patients

June 5, 2020

AstraZeneca’s cancer drug Calquence has shown initial signs of helping hospitalized COVID-19 patients get through the worst of the disease, as researchers scramble to repurpose existing treatments to help fight the deadly infection.

Results from the preliminary research involving 19 patients, which was backed by the United States National Institutes of Health, encouraged the British drug maker to explore the drug’s new use in a wider clinical trial announced in April.

Source: reuters.com

'Operation Warp Speed' is fueling vaccine fears, two top experts worry

June 5, 2020

The federal government's "Operation Warp Speed" vaccine program, with its emphasis on quick production and testing of experimental coronavirus vaccines, is fueling fears already stirred up by vaccine skeptics, two experts said Friday.

The approach itself is not unreasonable, said Dr. Peter Hotez, dean of the National School of Tropical Medicine and professor of pediatrics and molecular virology and microbiology at Baylor College of Medicine. But the way it's being communicated is scaring people, he told CNN.

Source: cnn.com

Special Report: COVID deepens the other opioid crisis - a shortage of hospital painkillers

June 9, 2020

As opioid pills and patches fueled a two-decade epidemic of overdoses in the United States, hospitals faced chronic shortages of the same painkillers in injectable form - narcotics vital to patients on breathing machines. For years, hospitals chased supplies, sometimes resorting to inferior substitutes. The shortfall grew so dire in 2018 that a drug maker sent letters advising hospitals they could use batches of opioid syringes potentially containing hazardous contaminants - so long as they filtered each dose.

Source: reuters.com

Johnson & Johnson to begin human trials for coronavirus vaccine in late July, earlier than expected

June 10, 2020

Johnson & Johnson announced Wednesday its early-stage human trial for a potential coronavirus vaccine will begin in the second half of July, earlier than its initial forecast of September. “Based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities, we have been able to further accelerate the clinical development of our investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant,” J&J’s Chief Scientific Officer Paul Stoffels said in a press release.

Source: cnbc.com


Opioid Dependence After Heart Surgery Linked to Amount Initially Prescribed

June 17, 2020

Opioid prescriptions after heart surgery might have turned some patients into chronic users, a study suggested, such that curbs on initial amounts prescribed may be warranted.

Among 35,817 patients who filled an opioid prescription within 14 days following coronary artery bypass grafting (CABG) or heart valve surgery, 9.6% of them became persistent opioid users by 90-180 days, according to Nimesh Desai, MD, PhD, of the Hospital of the University of Pennsylvania in Philadelphia, and colleagues.

Source: medpagetoday.com

WHO: New treatment only meant for severe COVID-19 cases

June 17, 2020

The World Health Organization (WHO) on Wednesday said a common drug shown to be effective in treating COVID-19 is meant for use only among those who are suffering the most severe symptoms of the disease, not those who have milder cases.

Source: thehill.com

HF Diagnosis Tied to 5-Year Death Risk in New T2D

June 23, 2020

Heart failure (HF) after a diabetes diagnosis was associated with a risk of death at 5 years, according to a Danish study.

In a pool of over 150,000 individuals newly diagnosed with type 2 diabetes, those who developed HF within 5 years had a three-times higher risk of all-cause mortality compared with those free of any cardiovascular or renal diseases (risk ratio 3.0, 95% CI 2.9-3.1), reported Bochra Zareini, MD, PhD, of Gentofte University Hospital in Copenhagen, and colleagues.


Benzodiazepine Use Decreases Infant Birth Weight

June 23, 2020

New study findings suggest benzodiazepine or benzodiazepine-like hypnotic use during pregnancy is associated with a mean decrease in birth weight of 79 g.

Although the magnitudes of the findings had no obvious clinical relevance, study authors determined the drugs should only be used in pregnancy after a thorough evaluation of the benefits and risks for the mother and child.

Source: mdmag.com

Avoiding Pain and Addiction After Sports-Injury Surgery

June 24, 2020

With opioid addiction soaring in the United States, it should come as good news that an opioid painkiller may not be needed after a sports-injury repair.


A mix of non-addictive medicines may be safer and equally successful in managing pain after shoulder or knee surgery, a study from Henry Ford Hospital in Detroit indicates.

Source: healthday.com

Budesonide Plus LAMA/LABA Significantly Reduces Annual COPD Exacerbation

June 24, 2020

Twice-daily budesonide/glycopyrrolate/formoterol significantly lowered exacerbations in patients with moderate or severe chronic obstructive pulmonary disease (COPD) versus a pair of double therapy inhalers, according to new findings.

Source: mdmag.com

Virus cases surge among the young, endangering older adults

June 24, 2020

Coronavirus cases are climbing rapidly among young adults in a number of states where bars, stores and restaurants have reopened — a disturbing generational shift that not only puts

them in greater peril than many realize but poses an even bigger danger to older people who cross their paths.

Source: apnews.com

U.S. demand outstripping supply of steroid treatment for COVID

June 25, 2020

Soaring hospital demand for the steroid dexamethasone, which British researchers say significantly reduces mortality among severely ill COVID-19 patients, is outstripping supply of the drug, but hospitals have so far been able to treat patients out of their inventories, according to Vizient Inc, a drug buyer for about half of U.S. hospitals.

Source: reuters.com

High Costs Lead Millions of Americans to Shop Abroad for Rx Drugs

June 26, 2020

More than 2 million Americans buy prescription drugs from other countries as a way around rising prices in the United States, a new study finds.

The analysis of nationwide survey data showed that 1.5% of adults got their prescription meds from outside the United States between 2015 and 2017.

Source: healthday.com

Sobering Data on Risks of Short-Term Oral Corticosteroids

July 6, 2020

Corticosteroid bursts as short as 2 weeks or less were still linked to severe adverse events among relatively healthy users, according to a large study from Taiwan.



For TNF Response in RA, Weight Matters

July 7, 2020

Patients with rheumatoid arthritis (RA) who were obese were significantly less likely to remain on treatment with tumor necrosis factor (TNF) inhibitors -- but so were those who were underweight, a large, long-term study determined.


Cabozantinib Active in Heavily Treated Bladder Cancer

July 7, 2020

Single-agent cabozantinib (Cabometyx, Cometriq) was well tolerated and showed activity in heavily pretreated metastatic bladder cancer patients with platinum-refractory disease, a phase II trial found.


Emotional Benefits of Probiotics; Phase III Success for ADHD Tx

July 8, 2020

Probiotics paired with prebiotics may hold a place in depression and anxiety treatment regimens, according to a review of seven studies. (The BMJ)

The investigational treatment vafidemstat -- an oral KDM1A inhibitor -- effectively reduced aggression in patients with borderline personality disorder, ADHD, and autism in the phase IIa Reimagine trial, Oryzon Genomics announced.


Behavioral Therapy a Front Runner for First-Line Insomnia Tx

July 8, 2020

A similar proportion of patients responded to behavioral therapy and zolpidem (Ambien) as first-line therapy for insomnia disorder, but the proportion of responders diverged with second-line treatments, a randomized trial found.


Isotretinoin Improves Quality of Life for Patients With Acne

July 8, 2020

Patients with acne who receive isotretinoin treatment achieve greater than 50% improvement in the quality of life by month 2.

Further, the findings of the new study suggest those who received such treatment can expect approximately four-fold to five-fold improvements in quality of life from baseline with a full course of isotretinoin. Based on the results, there may be new insights into how patients with acne perceive their response to isotretinoin treatment.

Source: mdmag.com


Xofluza Prophylaxis Mostly Stopped Flu in Japanese Families

July 8, 2020

Baloxavir marboxil (Xofluza) appeared effective in preventing household contacts of flu patients from developing infections themselves, a randomized trial in Japan showed.

Only 1.9% of contacts developed laboratory-confirmed clinical influenza after post-exposure prophylaxis with baloxavir compared to 13.6% of those assigned to placebo (adjusted RR 0.14, 95% CI 0.06-0.30, P


SARS-CoV-2 uses its surface spike protein to bind to human cells. Heparin, a blood thinner also available in non-anticoagulant formulations, binds tightly with the coronavirus’ surface spike protein. A team led by Robert Linhardt, PhD, professor of chemistry and chemical biology at RPI, predicted that this tight binding might interfere with SARS-CoV-2 infection.

Source: mdmag.com

WHO warns COVID-19 pandemic lowering childhood vaccination rates worldwide

July 15, 2020

The COVID-19 pandemic has led to a major plunge in childhood vaccination rates worldwide, and the World Health Organization (WHO) is warning the effects of children missing routine immunizations could become even worse than the pandemic itself.

Source: thehill.com

Johnson & Johnson to start human testing of COVID-19 vaccine next week

Jul 16, 2020

Several biopharma players are racing to deliver COVID-19 vaccines, and now Johnson & Johnson is revving up its plans for late-stage trials earlier than originally expected—and it's aiming far above the FDA's 50% efficacy bar for approval, executives said.

In a conference call Thursday, Johnson & Johnson chief scientific officer Paul Stoffels said the company has seen “strong” preclinical data, and it's now ready to kick off human testing next week.

Source: fiercepharma.com

Omega-3s May Protect Brain From Air Pollution

July 16, 2020

Omega-3 fatty acid levels appeared to weaken the inverse relationship between ambient fine particle exposure and brain aging, a prospective cohort study showed.

Older women exposed to high levels of air pollution who had the lowest levels of long-chain omega-3 polyunsaturated fatty acid in their blood had smaller brain volumes than women with the highest omega-3 fatty acid levels, reported Ka He, MD, ScD, of Columbia University in New York City, and co-authors.


Doctors And Dentists Still Flooding U.S. With Opioid Prescriptions

July 17, 2020

Despite widespread devastation caused by America's opioid epidemic, an investigation by NPR found that doctors and other health care providers still prescribe highly addictive pain medications at rates widely considered unsafe.

Public data, including new government studies and reports in medical literature, shows enough prescriptions are being written each year for half of all Americans to have one.

Source: npr.org


U.S. FDA accepts Acadia's application for dementia drug

July 20, 2020

The U.S. Food and Drug Administration on Monday accepted Acadia Pharmaceuticals Inc’s application for an antipsychotic drug to treat dementia patients with hallucinations and delusions.

The regulator said it had set April 3, 2021, as the action date to decide on the drug’s approval.

Source: reuters.com

ACE Inhibitors Associated With Lower Colorectal Cancer Risk in Large Cohort Study

July 21, 2020

Study data published in Hypertension suggest that treatment with certain antihypertensive medications may reduce risk for colorectal cancer. In a large, retrospective cohort study, patients who underwent treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) were found to be at lower risk for colorectal cancer over 3 years of follow-up. However, ACE inhibitors did not appear to affect colorectal cancer risk >3 years after cohort entry.

Source: gastroenterologyadvisor.com

Tocilizumab Raises GI Risks in Rheumatoid Arthritis

July 22, 2020

Patients with rheumatoid arthritis (RA) who were treated with tocilizumab (Actemra) had twice the risk of gastrointestinal perforations than those on tumor necrosis factor (TNF) inhibitors, Swedish researchers reported.

Compared with patients receiving TNF inhibitors, the fully adjusted hazard ratio for gastrointestinal perforation among tocilizumab users was 2.20 (95% CI 1.28-3.79, P=0.0045), according to Andrei Barbulescu, PhD, and colleagues from the Karolinska Institute in Stockholm.


It's not just dexamethasone: Other steroids may be used to treat critically ill COVID-19 patients, study says

July 22, 2020

Researchers at the Albert Einstein College of Medicine and Montefiore Health System led a study in which most of their patients took prednisone, another steroid in the same family as dexamethasone, and found patients with high inflammation levels were associated with a 75% reduction in risk of going on mechanical ventilation or dying.

Source: usatoday.com


RECALLS

Product Type

Product Description Classification Code Info Reason for Recall

Recalling Firm

Drugs Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle, This is a compounded drug not for resale, Store at room temperature, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419.

Class I Lot #: 01-09-2020:13@8, Exp. 7/7/2020

Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin.

MasterPharm LLC

Drugs Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA, Manufactured by: Granules India Limited, Hyderabad - 500-081, India

Class II a) 100 count 4920003A/May-21 4920004A/Jun-21 4920005A/Jun-21 4920009A/Nov-21 4920010A/May-22 4920011A/Jun-22 4920012A/Jun-22 4920013A/Jul-22 4920014A/Jul-22 4920015A/Aug-22 4920016A/Jan-23 b) 500 count 4920005B/Jun-21

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Granules Pharmaceuticals Inc.

Drugs Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin

Class II Batch# G808201 Aug-20 G808202 Aug-20 G808200 Aug-20 G900935 Dec-20

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above

Lupin Pharmaceuticals Inc.


Product Type


Recalling Firm

Limited, Goa INDIA NDC 68180-338-01

G901311 Dec-20 G900957 Dec-20 G900958 Dec-20 G901006 Dec-20 G904803 May-21 G904804 May-21 G906551 Jul-21 G906552 Jul-21 G907375 Aug-21 G908605 Oct-21 G908604 Oct-21 G002108 Jan-22 G002109 Jan-22 G002559 Feb-22 G002560 Feb-22

the acceptable intake level

Drugs Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09

Class II Batch # G807093 Jul-20 G807147 Jul-20 G807208 Jul-20 G807479 Jul-20 G807480 Jul-20 G807830 Jul-20 G807092 Jul-20 G809471 Jul-20 G808155 Aug-20 G808074 Aug-20 G808115 Aug-20 G900231 Nov-20 G900232 Nov-20 G903277 Mar-21 G903278 Mar-21 G903279 Mar-21 G903280 Mar-21 G903281 Mar-21 G903818 Apr-21 G904048 Apr-21 G904164 Apr-21




Product Type


Recalling Firm

G906548 Jul-21 G907239 Aug-21 G907255 Aug-21 G907256 Aug-21 G907263 Aug-21 G001802 Jan-22 G001804 Jan-22 G001803 Jan-22 G001805 Jan-22 G001806 Jan-22 G001807 Jan-22 G001808 Jan-22 G808154 Aug-20 G900227 Nov-20 G900228 Nov-20 G900229 Nov-20 G900230 Nov-20 G906549 Jul-21 G906550 Jul-21 G906547 Jul-21 G907279 Aug-21 G907364 Aug-21 G001809 Jan-22 G001801 Jan-22 G002563 Feb-22 G002564 Feb-22


Class II Batch # G808293 Aug-20 G808284 Aug-20 G808285 Aug-20 G808343 Aug-20 G901201 Dec-20 G901202 Dec-20 G906915 Jul-21 G906913 Jul-21 G906914 Jul-21




Product Type


Recalling Firm

G002135 Jan-22 G002849 Feb-22


Class II Batch # G807619 Jul-20 G807620 Jul-20 G807733 Jul-20 G807734 Jul-20 G807735 Jul-20 G807445 Jul-20 G807617 Jul-20 G807618 Jul-20 G808042 Jul-20 G808043 Jul-20 G807349 Jul-20 G807350 Jul-20 G807444 Jul-20 G807507 Jul-20 G807508 Jul-20 G807314 Jul-20 G807316 Jul-20 G807325 Jul-20 G807348 Jul-20 G807616 Jul-20 G807312 Jul-20 G807313 Jul-20 G807315 Jul-20 G808374 Aug-20 G808427 Aug-20 G808373 Aug-20 G808426 Aug-20 G900057 Oct-20 G900058 Oct-20 G900059 Oct-20 G900060 Oct-20 G900061 Oct-20 G900062 Oct-20 G900106 Oct-20 G900140 Oct-20 G900141 Oct-20 G900152 Oct-20 G809596 Oct-20 G809598 Oct-20




Product Type


Recalling Firm

G810182 Oct-20 G810183 Oct-20 G810184 Oct-20 G810185 Oct-20 G810186 Oct-20 G810187 Oct-20 G810188 Oct-20 G810189 Oct-20 G809554 Oct-20 G809556 Oct-20 G809557 Oct-20 G809558 Oct-20 G809559 Oct-20 G809548 Oct-20 G809549 Oct-20 G809550 Oct-20 G809551 Oct-20 G809552 Oct-20 G809553 Oct-20 G809555 Oct-20 G901004 Dec-20 G901005 Dec-20 G901053 Dec-20 G901002 Dec-20 G901003 Dec-20 G903182 Mar-21 G903183 Mar-21 G903236 Mar-21 G903237 Mar-21 G903238 Mar-21 G903155 Mar-21 G903156 Mar-21 G903157 Mar-21 G903158 Mar-21 G903159 Mar-21 G903178 Mar-21 G903179 Mar-21 G903180 Mar-


Product Type


Recalling Firm

21 G903181 Mar-21 G903239 Mar-21 G001837 Jan-22 G001860 Jan-22 G001861 Jan-22 G001905 Jan-22 G001933 Jan-22 G001934 Jan-22 G001763 Jan-22 G001764 Jan-22 G001765 Jan-22 G001766 Jan-22 G001767 Jan-22 G001795 Jan-22 G001836 Jan-22

Drugs Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% topical anesthetic, menthol 5% topical analgesic, Pkg Size 15 patches per box, Insurance NDC: 53225-1025-01, Mfg: Terrain Pharmaceuticals; Reno, NV, Prod # (NDC): 68788-7405-01, Preferred Pharmaceuticals, Inc., The Physicians Solutions.

Class II Lot Numbers: H0218Z, H1518J, I2018L, J2918C, L1018Q, A0419M, G0519G; Exp. 5/31/2021.

CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.

Preferred Pharmaceuticals, Inc.

Drugs Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2489-00 for box; 70518-2489-01 per unit dose.

Class II Lot #: B0796217-020920, Exp. 02/28/2021

FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.

RemedyRepack Inc.

Drugs Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx

Class II Lot #s: AK6003C, Exp. 10/31/2020; AK6004B, Exp. 11/30/2020;

cGMP deviations: Lots recalled were not manufactured in

Keryx Biopharmaceuticals, Inc.


Product Type


Recalling Firm

Biopharmaceuticals, Inc., 245 First Street Suite 1400, Cambridge, MA 02142, NDC: 59922-631-01.

CBMKF, CBMKH, Exp. 08/31/2020; CCKSM, Exp. 09/30/2020; CBWKN, Exp. 11/30/2020; CCSTZ, CCWZB, Exp. 05/31/2021; CCYSF, CCYSG, CCWZC, Exp. 06/30/2021; CDCTB, CDCSZ, Exp. 07/31/2021.

conformance with the FDA-approved manufacturing process for Auryxia.

Drugs Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, Manufactured for: EMD Serono, Inc., Rockland, MD 02370, NDC: 44087-1225-1

Class II Lot # 8J025A; 8J025B, Exp. 09/30/2020

Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.

EMD Serono, Inc.

Drugs Koala Hand Sanitizer, Soothing Eucalyptus, 16 FL OZ., Antibacterial, (Ethyl Alcohol 68%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665

Class II Lot #: 40820, Exp. 4/8/23

Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.

Beaming White LLLC

Drugs Koala Hand Sanitizer, Menthol, 16 FL OZ., Antibacterial, (Ethyl Alcohol 69%), Manufactured by Beaming White LLC, 1205

Class II Lot #: 40920, Exp. 4/9/23; 41320, Exp. 4/13/23; 41420, Exp. 4/14/23; 41620,

Subpotent Drug: active ingredient ethanol tested below label claim and there

Beaming White LLC


Product Type


Recalling Firm

NE 95th St., Vancouver, WA 98665

Exp. 4/16/23; 41720, 41720-2, Exp. 4/17/23

is presence of undeclared isopropyl alcohol.

Drugs Koala Hand Sanitizer, Unscented, 16 FL OZ., Antibacterial, (Ethyl Alcohol 70%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665

Class II Lot#: 42220, Exp. 4/22/23

Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.

Beaming White LLC

Drugs Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppressant), guaifenesin (expectorant), 4 FL OZ. bottle (118 mL), Distributed by: Pfizer, Madison, NJ 07940 USA, UPC: 50300318760128, NDC: 0031-8760-12.

Class II Lot #s: 02177, 02178, Exp. 01/31/2022

Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.

Glaxosmithkline Consumer Healthcare Holdings

Drugs Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (237 mL), Distributed by: Pfizer Madison, NJ 07940, Made in Canada, UPC: 60300312234196, NDC: 0031-2234-19.

Class II Lot CL8292, Exp. 09/30/2021

Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.

Glaxosmithkline Consumer Healthcare Holdings

Drugs Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toronto, Ontario, Canada, Manufactured for: Apotex Corp. Weston, FL, Distributed by: Major Pharmaceuticals, Livonia, MI 48152 NDC 00904-5794-61

Class II Lot T-02134, Exp. 09/2020

CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.

The Harvard Drug Group


Product Type


Recalling Firm

Drugs Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc., Farmingdale, NY, Preferred Pharmaceuticals, Anaheim, CA NDC: 68788-6932-01

Class II J0119M, K1419L, K2719J, A0220H; Exp. 12/2020

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Preferred Pharmaceuticals, Inc.

Drugs Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial

Class II Lot #: 2H071219P, 2H0712019P, 2H07122019P, Exp. 7/12/2021

Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin

BIOTA Biosciences LLC

Drugs Sterile Curcumin, 4mg/mL, 10mL vial

Class II Lot #: 2H071219CCD, 2H0712019CCD, 2H07122019CCD, Exp. 7/12/2021



Drugs Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial

Class II Lot #: 101019P, 1010019P,10102019P, Exp. 10/10/2021

Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved



Product Type


Recalling Firm

Cannabidiol and Curcumin

Drugs Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial

Class II Lot #: 101019PC, 1010019PC, 10102019PC, Exp. 10/10/2021



Drugs Sterile Curcumin 50mg/mL, 10 mL vial

Class II Lot #: 071219CCD, 0712019CCD, 07122019CCD, Exp. 7/12/2021



Drugs amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-01

Class II HA07419A 1/31/2021 HB00119A 1/31/2021 HB00219A 1/31/2021 HB00319A 1/31/2021; HB00419A 2/28/2021 HB00519A 2/28/2021 HB00619A 2/28/2021 HB00719A 2/28/2021 HB00819A 2/28/2021


Amneal Pharmaceuticals of New York, LLC


Product Type


Recalling Firm

HB00919A 2/28/2021 HB01019A 2/28/2021 HB05119A 2/28/2021 HB05219A 2/28/2021 HB05319A 2/28/2021 HB05419A 2/28/2021 HB05519A 2/28/2021 HB09519A 2/28/2021 HB09619A 2/28/2021 HB09719A 2/28/2021 HB09819A 2/28/2021 HB09919A 2/28/2021; HC08219A 3/31/2021 HC08319A 3/31/2021 HC08419A 3/31/2021 HC08519A 3/31/2021 HC09019A 3/31/2021 HC09119A 3/31/2021 HC09219A 3/31/2021 HC09319A 3/31/2021 HC09419A 3/31/2021; HD03419B 4/30/2021


Product Type


Recalling Firm

HD03519B 4/30/2021 HD03619B 4/30/2021 HD03719B 4/30/2021 HD03819B 4/30/2021 HD03919B 4/30/2021 HD04019B 4/30/2021 HD04119B 4/30/2021 HD04219A 4/30/2021 HD05819A 4/30/2021 HD05919A 4/30/2021 HD06019A 4/30/2021 HD06119A 4/30/2021 HD06219A 4/30/2021 HD06319A 4/30/2021 HD06419A 4/30/2021 HD09019A 4/30/2021 HD09119A 4/30/2021 HD09219A 4/30/2021 HE01219B 4/30/2021 HE01319B 4/30/2021 HE01419B 4/30/2021 HE01519B 4/30/2021;


Product Type


Recalling Firm

HE01619A 5/31/2021 HE01719A 5/31/2021 HE01819A 5/31/2021 HE04419A 5/31/2021 HE04519A 5/31/2021 HE04619A 5/31/2021 HE04719A 5/31/2021 HE04819A 5/31/2021 HE04919A 5/31/2021 HE05019A 5/31/2021 HE05119A 5/31/2021 HE05219A 5/31/2021 HE05319A 5/31/2021 HE07219A 5/31/2021 HE07319A 5/31/2021 HE07419A 5/31/2021 HE07519A 5/31/2021 HE07619A 5/31/2021 HF02219A 5/31/2021 HF02319A 5/31/2021; HF02419A 6/30/2021 HF02519A 6/30/2021


Product Type


Recalling Firm

HF02619A 6/30/2021 HF02719A 6/30/2021 HF02819A 6/30/2021 HF02919A 6/30/2021 HF03019A 6/30/2021 HF03119A 6/30/2021 HF03219A 6/30/2021 HF03319A 6/30/2021 HF05419A 6/30/2021; HF03918A 6/30/2020 HF04018A 6/30/2020 HF04118A 6/30/2020 HF04218A 6/30/2020 HF04318A 6/30/2020 HF04418A 6/30/2020 HF06518A 6/30/2020 HF06818B 6/30/2020 HF06918B 6/30/2020 HF07018B 6/30/2020 HF07118B 6/30/2020 HF07218A 6/30/2020 HF07318A 6/30/2020


Product Type


Recalling Firm

HF07418A 6/30/2020 HF08318A 6/30/2020 HF08418A 6/30/2020 HF08518A 6/30/2020; HF11219A 6/30/2021 HF11319A 6/30/2021 HF11419A 6/30/2021 HF11519A 6/30/2021 HF11619A 6/30/2021 HF11719A 6/30/2021 HF11819A 6/30/2021 HF11919A 6/30/2021 HF12019A 6/30/2021 HG00719A 6/30/2021 HG00819A 6/30/2021 HG00919A 6/30/2021 HG01019A 6/30/2021 HG01119A 6/30/2021 HG01219A 6/30/2021 HG01319A 6/30/2021 HG01419A 6/30/2021; HG01519A 7/31/2021


Product Type


Recalling Firm

HG01619A 7/31/2021 HG02919A 7/31/2021 HG03019A 7/31/2021 HG03119A 7/31/2021 HG03219A 7/31/2021 HG03319A 7/31/2021 HG03419A 7/31/2021 HG03519A 7/31/2021 HG03619A 7/31/2021 HG03719A 7/31/2021 HG03819A 7/31/2021; HH08218A 8/31/2020 HH08318A 8/31/2020 HH08418A 8/31/2020 HH08518A 8/31/2020 HH08618A 8/31/2020 HH08718A 8/31/2020 HH08818A 8/31/2020 HH08918A 8/31/2020 HH09018A 8/31/2020 HH09118A 8/31/2020 HH09218A 8/31/2020


Product Type


Recalling Firm

HH09318A 8/31/2020 HH09418A 8/31/2020 HH09518A 8/31/2020 HH09618A 8/31/2020 HH11218A 8/31/2020 HH11318A 8/31/2020 HH11418A 8/31/2020 HH11518A 8/31/2020; HH11618A 9/30/2020 HH11718A 9/30/2020 HJ04818A 9/30/2020 HJ04918A 9/30/2020 HJ08518A 9/30/2020; HJ08618A 10/31/2020 HJ08718A 10/31/2020 HJ08818A 10/31/2020 HJ08918A 10/31/2020 HJ09018A 10/31/2020 HJ09118A 10/31/2020 HK03718A 10/31/2020 HK03818A 10/31/2020 HK03918A 10/31/2020


Product Type


Recalling Firm

HK04018A 10/31/2020 HK04118A 10/31/2020 HK04218A 10/31/2020 HK04318A 10/31/2020 HK04418A 10/31/2020 HK04518A 10/31/2020 HK04618A 10/31/2020 HK09318A 10/31/2020 HK09418A 10/31/2020 HK09518A 10/31/2020 HK09618A 10/31/2020 HK09718A 10/31/2020; HM00218A 12/31/2020 HM00318A 12/31/2020 HM00418A 12/31/2020 HM00518A 12/31/2020 HM00618B 12/31/2020 HM00718B 12/31/2020 HM00818B 12/31/2020 HM00918B 12/31/2020 HM01018B 12/31/2020; HM02918A 1/31/2021


Product Type


Recalling Firm

HM03018A 1/31/2021 HM03218A 1/31/2021 HM03318A 1/31/2021 HM03418A 1/31/2021 HM03518A 1/31/2021 HM03618A 1/31/2021 HM03718A 1/31/2021 HM03818A 1/31/2021

Drugs amneal Metformin Hydrochloride Extended-release Tablets, USP 500 mg Rx Only 90 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08907 NDC 65162-178-09

Class II AM190123A 1/31/2021 AM190193A 1/31/2021 AM190194A 1/31/2021 AM190195A 1/31/2021 AM190196A 1/31/2021 AM190197A 1/31/2021 AM190198A 1/31/2021 AM190199A 1/31/2021 AM190200A 2/28/2021 AM190201A 2/28/2021 AM190202A 2/28/2021 AM190269A 2/28/2021 AM190270A 2/28/2021 AM190271A 2/28/2021




Product Type


Recalling Firm

AM190272A 2/28/2021 AM190289A 2/28/2021 AM190290A 2/28/2021 AM190291A 2/28/2021 AM190292A 2/28/2021 AM190293A 2/28/2021 AM190294A 2/28/2021 AM190549A 4/30/2021 AM190550A 4/30/2021 AM190551A 4/30/2021 AM190552A 4/30/2021 AM190553A 4/30/2021 AM190554A 4/30/2021 AM190555A 5/31/2021 AM190556A 5/31/2021 AM190586A 5/31/2021 AM190587A 5/31/2021 AM190588A 5/31/2021 AM190589A 5/31/2021 AM190590A 5/31/2021 AM190605A 5/31/2021 AM190673A 6/30/2021


Product Type


Recalling Firm

AM190707A 6/30/2021 AM190708A 6/30/2021 AM190709A 6/30/2021 AM190710A 6/30/2021 AM190714C 6/30/2021 AM190751C 6/30/2021 AM190752C 6/30/2021 AM190753A 8/31/2021 AM190754A 8/31/2021 AM190755A 8/31/2021 AM190756A 8/31/2021 AM190757A 8/31/2021 AM190929A 8/31/2021 AM190930A 8/31/2021 AM190931A 8/31/2021 AM190932A 8/31/2021 AM190933A 8/31/2021 AM190995A 8/31/2021 AM191000A 8/31/2021 AM191001A 8/31/2021 AM191002A 8/31/2021 AM191003A 8/31/2021


Product Type


Recalling Firm

AM191034A 9/30/2021 AM191035A 9/30/2021 AM191036A 9/30/2021 AM191037A 9/30/2021 AM191038A 9/30/2021 AM191039A 9/30/2021 AM191086A 9/30/2021

Drugs amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx Only, 500 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-50

Class II AM180641A 6/30/2020 AM180642A 6/30/2020 AM180643A 6/30/2020 AM180644A 6/30/2020 AM180645A 6/30/2020 AM180646A 6/30/2020 AM180647A 6/30/2020 AM180880A 7/31/2020 AM180881A 7/31/2020 AM180882A 7/31/2020 AM180883A 7/31/2020 AM180884A 7/31/2020 AM180885A 7/31/2020 AM180886A 7/31/2020 AM180887A 7/31/2020




Product Type


Recalling Firm



Product Type


Recalling Firm

AM181236A 9/30/2020 AM181237A 9/30/2020 AM181238A 9/30/2020 AM181239A 9/30/2020 AM181240A 9/30/2020 AM181242A 9/30/2020 AM181243A 9/30/2020 AM181314A 10/31/2020 AM181315A 11/30/2020 AM190121B 12/31/2020 AM190122B 12/31/2020 AM190713AA 6/30/2021 AM191248A 10/31/2021 AM191249A 10/31/2021 AM200192 1/31/2022 AM200322A 2/28/2022

Drugs amneal Metformin Hydrochloride Extended-release Tablets, USP, 500 mg Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213 India Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-178-10

Class II AM181118AA 10/31/2020 AM181191AA 9/30/2020 AM181192AA 9/30/2020 AM181235AA 9/30/2020 AM181236AA 9/30/2020 AM181237AA 9/30/2020




Product Type


Recalling Firm

AM181240AA 9/30/2020 AM181241AA 9/30/2020 AM181242AA 9/30/2020 AM181243AA 9/30/2020 AM181244AA 10/31/2020 AM181268AA 10/31/2020 AM181269AA 10/31/2020 AM181270AA 10/30/2020 AM181271AA 10/31/2020 AM181272AA 10/31/2020 AM181273AA 10/31/2020 AM181274AA 10/31/2020 AM181275AA 10/31/2020 AM181276AA 10/31/2020 AM181277AA 10/31/2020 AM181307AA 10/31/2020 AM181308AA 10/31/2020 AM181309AA 10/31/2020 AM181310AA 10/31/2020 AM181311AA 10/31/2020 AM181313AA 10/31/2020 AM181314AA 10/31/2020


Product Type


Recalling Firm

AM181315AA 11/30/2020 AM181316AA 11/30/2020 AM181317AA 12/31/2020 AM181419AA 11/30/2020 AM181420AA 11/30/2020 AM181421AA 11/30/2020 AM181422AA 11/30/2020 AM181423AA 11/30/2020 AM181424AA 11/30/2020 AM181425AA 11/30/2020 AM181430BA 12/31/2020 AM181455AA 12/31/2020 AM181456AA 12/31/2020 AM181457AA 12/31/2020 AM181458AA 12/31/2020 AM181459AA 12/31/2020 AM181460AA 12/31/2020 AM181461AA 12/31/2020 AM181462AA 12/31/2020 AM181463AA 12/31/2020 AM181464AA 12/31/2020 AM181465AA 12/31/2020


Product Type


Recalling Firm

AM190054AA 12/31/2020 AM190055AA 12/31/2020 AM190057AA 12/31/2020 AM190058AA 12/31/2020 AM190102AA 12/31/2020 AM190103AA 12/31/2020 AM190104AA 12/31/2020 AM190105AA 12/31/2020 AM190106AA 12/31/2020 AM190107AA 12/31/2020 AM190108AA 12/31/2020 AM190120AA 12/31/2020 AM190633AA 5/31/2021 AM190634AA 5/31/2021 AM190635AA 5/31/2021 AM190636AA 5/31/2021 AM190637AA 5/31/2021 AM190638AA 5/31/2021 AM190640AA 5/31/2021 AM190641AA 5/31/2021 AM190642AA 5/31/2021 AM190664AA 5/31/2021


Product Type


Recalling Firm

AM190665AA 5/31/2021 AM190666AA 5/31/2021 AM190667AA 5/31/2021 AM190668AA 5/31/2021 AM190669AA 6/30/2021 AM190670AA 6/30/2021 AM190671AA 6/30/2021 AM190672AA 6/30/2021 AM190714AA 6/30/2021 AM190934A 8/31/2021 AM190991A 8/31/2021 AM190992A 8/31/2021 AM190993A 8/31/2021 AM190994A 8/31/2021 AM191040A 9/30/2021 AM191041A 9/30/2021 AM191083A 9/30/2021 AM191084A 9/30/2021 AM191085A 9/30/2021 AM191091A 9/30/2021 AM191092A 9/30/2021 AM191105A 9/30/2021


Product Type


Recalling Firm


drug information updateperform-pport02.inetuhosted.net/sites/default/files...l1) blocking antibody...

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