[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…
Rusty’s Seafood Market Issues Allergy Alert on Undeclared Allergens (Fish, Crustacean, Shellfish, Eggs, Milk, Soy, and Wheat) in all “Captain Rusty’s Seafood Dips”
Summary Company Announcement Date: June 12, 2020 FDA Publish Date: June 12, 2020 Product Type: Food & Beverages Seafood/Seafood Product Allergens Reason for Announcement: Recall Reason Description Undeclared fish, shellfish, wheat, eggs, soy, and milk Company Name: Rusty’s Seafood Market Brand Name: Brand Name(s) Captain Rusty’s Product Description: Product Description Undeclared fish, shellfish, wheat, eggs,…
NOW Health Group Inc. Voluntarily Recalls NOW Real Food ®Raw Macadamia Nuts Because of Possible Health Risk
Summary Company Announcement Date: June 12, 2020 FDA Publish Date: June 12, 2020 Product Type: Food & Beverages Nuts & Nut Products Foodborne Illness Reason for Announcement: Recall Reason Description Potential Salmonella contamination Company Name: NOW Health Group, Inc. Brand Name: Brand Name(s) Now Real Food Product Description: Product Description Raw Macadamia Nuts Company Announcement…
RONG SHING TRADING NY INC. of Brooklyn, NY is Recalling its 21.1oz (600g) of Xi Zhi Liang Fruit Jelly Cup
Summary Company Announcement Date: June 11, 2020 FDA Publish Date: June 11, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential choking hazard Company Name: Rong Shing Trading NY Inc. Brand Name: Brand Name(s) Xi Zhi Liang Product Description: Product Description Konjac powder jelly cups Company Announcement RONG SHING TRADING NY…
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…
Chinese Manufacturer Charged with Exporting Misbranded and Defective Masks Falsely Purporting to be N95 Respirators
Department of JusticeU.S. Attorney’s OfficeDistrict of New Jersey FOR IMMEDIATE RELEASEFriday, June 5, 2020 NEWARK, N.J. – A Chinese manufacturer was charged today with producing and exporting to the United States in the midst of the COVID-19 pandemic nearly half a million misbranded and defective masks that falsely purported to be N95 respirators, U.S. Attorneys Craig…
Medtronic recalls StealthStation auto-registration feature due to inaccuracies during deep brain stimulation (DBS) procedures
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Medtronic StealthStation Auto-registration Feature from the Cranial software version 3.0 or newer (3.0, 3.1, 3.1.1) with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License…
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,…