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…
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,…
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…
Transport Media Safety Risk – Use Compatible Transport Media with SARS-CoV-2 Tests that Use Bleach – Letter to Clinical Laboratory Staff and Health Care Providers
The U.S. Food and Drug Administration (FDA) reminds laboratory staff to use transport media (the liquid that maintains a specimen sample while it is transported to a laboratory) that are compatible with the SARS-CoV-2 testing platforms and the processes used in their laboratory to process samples collected from people who are being tested for SARS-CoV-2….
Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, Due to Detection of N-Nitrosodimethylamine (NDMA) Impurity
Summary Company Announcement Date: May 29, 2020 FDA Publish Date: June 01, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to detection of N-Nitrosodimethylamine (NDMA) Company Name: Amneal Pharmaceuticals LLC Brand Name: Brand Name(s) Product Description: Product Description Metformin Hydrochloride Extended-Release Tablets, USP 500mg and 750mg Company Announcement Amneal Pharmaceuticals LLC Bridgewater,…
Epinephrine Auto-Injector Devices by Amneal and Impax: CDER Alert – FDA Alerts Patients and Health Care Professionals About Device Malfunction
[Posted 06/01/2020] AUDIENCE: Patient, Health Professional, Pharmacy, Risk Manager ISSUE: FDA is alerting patients, caregivers and health care professionals to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present. If the auto-injector is missing the yellow “stop collar” component, the device has…
The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication
UPDATE: On June 1, 2020, Allergan launched a dedicated multi-channel campaign to contact patients who may not be aware of the July 24, 2019, recall of BIOCELL textured breast implants and tissue expanders. People who are not aware of the BIOCELL recall or do not know the type of implant theyhave or their implant history, should: Contact…
Apotex Corp. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets 500mg Due to the Detection of N-nitrosodimethylamine (NDMA)
Summary Company Announcement Date: May 27, 2020 FDA Publish Date: May 28, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to detection of N-Nitrosodimethylamine (NDMA) Company Name: Apotex Corp Brand Name: Brand Name(s) Apotex Corp Product Description: Product Description Metformin Hydrochloride Extended-Release Tablets, USP 500mg Company Announcement Apotex Corp is voluntarily recalling…