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

Summary Company Announcement Date: June 18, 2020 FDA Publish Date: June 18, 2020 Product Type: Drugs Over-the-Counter Drugs Reason for Announcement: Recall Reason Description Incorrect dosing cups Company Name: GSK Consumer Healthcare Brand Name: Brand Name(s) Robitussin Product Description: Product Description Cough and cold products Company Announcement GSK Consumer Healthcare is voluntarily recalling to the…

Certain COVID-19 Serology/Antibody Tests Should Not Be Used – Letter to Clinical Laboratory Staff and Health Care Providers

The U.S. Food and Drug Administration (FDA) recommends that clinical laboratories and health care providers stop using COVID-19 antibody tests that are listed on FDA’s “removed” test list, found on the FDA’s FAQs on Testing for SARS-CoV-2 webpage.  The “removed” test list includes tests where significant clinical performance problems were identified that cannot be or…

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

[Posted 06/15/2020] AUDIENCE: Health Professional, Pharmacy, Patient ISSUE: FDA is warning health care providers 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…

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

Summary Company Announcement Date: June 11, 2020 FDA Publish Date: June 11, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Detection of N-Nitrosodimethylamine (NDMA) Company Name: Lupin Pharmaceuticals, Inc Brand Name: Brand Name(s) Product Description: Product Description Metformin Hydrochloride Extended-release Tablets Company Announcement Lupin Pharmaceuticals Inc. is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets…

Allergan Aesthetics Launches Dedicated Multi-Channel Campaign to Contact Patients Who May Not Be Aware of The Biocell® Recall

Summary Company Announcement Date: June 01, 2020 FDA Publish Date: June 01, 2020 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Increased risk of BIA-ALCL Company Name: Allergan Aesthetics Brand Name: Brand Name(s) Product Description: Product Description Breast Implants Company Announcement Allergan Aesthetics, an AbbVie company (NYSE: ABBV), is initiating a new digital…

Marksans Pharma Limited Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)

Summary Company Announcement Date: June 02, 2020 FDA Publish Date: June 05, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to detection of N-Nitrosodimethylamine (NDMA) Company Name: Marksans Pharma Limited, India Brand Name: Brand Name(s) Time-Cap Labs, Inc. Product Description: Product Description Metformin Hydrochloride Extended-Release Tablets, USP 500mg Company Announcement Marksans Pharma…

Teva Pharmaceuticals USA, Inc. Initiates Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP 500 mg and 750 mg Due to Detection of N-Nitrosodimethylamine (NDMA)

Summary Company Announcement Date: June 02, 2020 FDA Publish Date: June 05, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to detection of N-Nitrosodimethylamine (NDMA) Company Name: Teva Pharmaceuticals USA Inc. Brand Name: Brand Name(s) Product Description: Product Description Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg Company Announcement Teva Pharmaceuticals USA,…

Two Neuromuscular Blocking Agents: CDER Alert – FDA Alerts Health Care Professionals to the Temporary Absence of Warning Statement on the Vial Caps

[Posted 06/03/2020] AUDIENCE: Health Professional, Pharmacy, Risk Manager ISSUE:  FDA is notifying health care professionals about the temporary absence of the “paralyzing agent” warning statement embossed on the vial caps of two neuromuscular blocking agents, vecuronium bromide for injection, 10 mg and 20 mg per vial and rocuronium bromide injection 50 mg/5 mL and 100 mg/10…