Summary Company Announcement Date: October 22, 2019 FDA Publish Date: October 23, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description May Contain N-Nitrosodimethylamine (NDMA) Company Name: Sanofi Brand Name: Brand Name(s) Product Description: Product Description Zantac 150, Zantac 150 Cool Mint, Zantac 75 (OTC Products) Company Announcement As a precautionary measure, Sanofi on…
Perrigo Company plc Issues Voluntary Worldwide Recall of Ranitidine Due to Possible Presence of Impurity, N-nitrosodimethylamine (NDMA) Impurity in the Product
Summary Company Announcement Date: October 23, 2019 FDA Publish Date: October 23, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of N-Nitrosodimethylamine (NDMA) Company Name: Perrigo Company plc Brand Name: Brand Name(s) Perrigo Company plc Product Description: Product Description Ranitidine (all pack sizes) Company Announcement As a precautionary measure, Perrigo Company plc…
Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All Ranitidine Products in the U.S. Market
Summary Company Announcement Date: October 23, 2019 FDA Publish Date: October 23, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Contains N-Nitrosodimethylamine (NDMA) Company Name: Dr. Reddy’s Laboratories Ltd. Brand Name: Brand Name(s) Dr. Reddy’s, Kroger, Walgreens, and others Product Description: Product Description Ranitidine Tablets & Capsules Company Announcement Dr. Reddy’s Laboratories Ltd….
Fitoterapia USA Inc. Issues Voluntary Nationwide Recall of MERO MACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLEMENT Due to Presence of Active Ingredient Tadalafil
Summary Company Announcement Date: September 16, 2019 FDA Publish Date: September 16, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Tadalafil Company Name: Fitoterapia USA Inc. Brand Name: Brand Name(s) Product Description: Product Description MACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLEMENT Company Announcement Fitoterapia USA Inc., is voluntarily recalling 19,000…
Teleflex Medical Recalls the Hudson RCI Sheridan and Sheridan Endotracheal Tubes Due to Risk of the Sheridan Connector Disconnecting from the Breathing Circuit
Hudson RCI® Sheridan LTS® 4.0 mm Hudson RCI® Sheridan® Preformed 3.0 mm Hudson RCI® Sheridan LTS® 5.0 mm Hudson RCI® Sheridan® Preformed 3.5 mm Hudson RCI® Sheridan LTS® 6.0 mm Hudson RCI® Sheridan® Preformed 4.0 mm Hudson RCI® Sheridan/CF® 3.0 mm Hudson RCI® Sheridan® Preformed 4.5 mm Hudson RCI® Sheridan/CF® 3.5 mm Hudson RCI® Sheridan®…
Viatrexx Bio Incorporated Issues Voluntary Nationwide Recall of Sterile Injectables due to a Lack of Sterility Assurance
Summary Company Announcement Date: October 15, 2019 FDA Publish Date: October 15, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Lack of sterility assurance Company Name: Viatrexx Bio Incorporated Brand Name: Brand Name(s) Product Description: Product Description Sterile injectable products Company Announcement Viatrexx Bio Incorporated, Newark, Delaware is voluntarily recalling 10 mL sterile…
Important Drug Information – Humate-P [Antihemophilic Factor/von Willebrand Factor Complex (Human)]
DATE NOTIFICATION INITIATED: October 3, 2019 PRODUCT / LOT NUMBER: Humate-P [Antihemophilic Factor/von Willebrand Factor Complex (Human)] Lots of All Fill Sizes (600, 1200, 2400 IUs) distributed by CSL Behring since February 2019 MANUFACTURER: CSL Behring LLCMarburg, Germany REASON: CSL Behring LLC is alerting customers to a misalignment in the printing of the data on…
2019 Biologics Recalls
July 19, 2019 Drug Recall: Kogenate FS antihemophilic factor (recombinant) 2000 IU Lot Number27118RK27119CG Bayer is voluntarily recalling two lots of Kogenate® FS antihemophilic factor (recombinant) 2000 IU vials in the United States to the patient level. Some vials from these two lots that were labeled as Kogenate FS actually contain the FVlll hemophilia A…
Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP
Summary Company Announcement Date: September 23, 2019 FDA Publish Date: September 19, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to the Detection of N-Methylnitrosobutyric acid (NMBA) Company Name: Torrent Pharmaceuticals Limited Brand Name: Brand Name(s) Torrent Pharma Product Description: Product Description Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP Company…
Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to An Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA), in the Product
Summary Company Announcement Date: September 23, 2019 FDA Publish Date: September 23, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) Company Name: Sandoz Inc. Brand Name: Brand Name(s) Sandoz Inc. Product Description: Product Description Ranitidine Hydrochloride Capsules Company Announcement Sandoz Inc. is voluntarily…