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…
Understanding the Regulatory Terminology of Potential Preventions and Treatments for COVID-19
Image There’s a lot of confusion about which medical products might work to prevent or treat coronavirus disease 2019 (COVID-19). Scientists are working hard to develop a number of potential drugs for the prevention or treatment of coronavirus, but none are currently approved by the FDA for these purposes. Some investigational drugs are already in clinical…
Medtronic Recalls HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Due to Risk of Breaks and Tears During Set Up
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 HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Model Numbers: HVAD™ Pump Outflow Graft: 1125 HVAD™ Pump Implant Kit: 1103 HVAD™ Implant Accessories Kit: 1153…
Use the Correct Cycle and Compatible N95 Respirators When Decontaminating Respirators with STERRAD Sterilization Systems – Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) reminds reprocessing staff in health care facilities to use the correct decontamination cycle associated with certain models of the Advanced Sterilization Products (ASP) STERRAD Sterilization Systems and to only decontaminate compatible N95 or N95-equivalent respirators for reuse during the COVID-19 pandemic. ASP STERRAD Sterilization Systems use vaporized hydrogen…
Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Super Potency
Summary Company Announcement Date: May 22, 2020 FDA Publish Date: May 22, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Super potency Company Name: Acella Pharmaceuticals, LLC Brand Name: Brand Name(s) Product Description: Product Description 30-mg, 60-mg and 90-mg NP Thyroid® Company Announcement Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13…
Biota Biosciences Issues Voluntary Nationwide Recall of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables Because They Were Marketed Without FDA Approval
Summary Company Announcement Date: May 20, 2020 FDA Publish Date: May 20, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Unapproved new drug Company Name: Biota Biosciences, LLC Brand Name: Brand Name(s) Biota Biosciences Product Description: Product Description Cannabidiol (CBD) Complex, Curcumin Complex, Cannabidiol + Curcumin Company Announcement Biota Biosciences is voluntarily recalling…