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…

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…

Apotex Corp. Issues Voluntary Nationwide Recall of Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) due to the potential for Detection of an Amount of Unexpected Impurity,N-nitrosodimethylamine (NDMA) Impurity in the product

Summary Company Announcement Date: September 25, 2019 FDA Publish Date: September 25, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) Company Name: Apotex Corp. Brand Name: Brand Name(s) Apotex Corp. Product Description: Product Description Ranitidine Tablets 75mg and 150mg Company Announcement Apotex Corp. is voluntarily, on…

Mavidon Issues Voluntary Worldwide Recall of LemonPrep® Tubes and Single Use Cups

Summary Company Announcement Date: September 26, 2019 FDA Publish Date: September 26, 2019 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Burkholderia cepacia Company Name: Mavidon Brand Name: Brand Name(s) Product Description: Product Description Skin prepping lotion for enhancement of signal quality at electrode site Company Announcement Mavidon is voluntarily recalling 21 lots…

URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices: FDA Safety Communication

Date Issued: October 1, 2019 The U.S. Food and Drug Administration (FDA) is informing patients, health care providers and facility staff, and manufacturers about cybersecurity vulnerabilities that may introduce risks for certain medical devices and hospital networks. The FDA is not aware of any confirmed adverse events related to these vulnerabilities. However, software to exploit…