[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….
Federal Court Issues Temporary Restraining Order against Fort Davis Businessman Offering Fraudulent Coronavirus Cures/Treatments
Department of JusticeU.S. Attorney’s OfficeWestern District of Texas FOR IMMEDIATE RELEASETuesday, June 2, 2020 Today, federal authorities served a civil injunction against 73-year-old Fort Davis resident Marc “White Eagle” Travalino in an effort to combat alleged fraud related to the coronavirus (COVID-19) pandemic, announced Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division;…
Meds2Go Express Pharmacy, Inc. Sentenced for Role in Drug Diversion Scheme
Department of JusticeU.S. Attorney’s OfficeSouthern District of West Virginia FOR IMMEDIATE RELEASETuesday, June 2, 2020 Pharmacy Shut Down and Ordered to Pay $250,000 in Community Restitution and Forfeiture CHARLESTON, W.Va. – Meds2Go Express Pharmacy, Inc. (Meds2Go), a pharmacy located in Alum Creek in Lincoln County, was sentenced for money laundering, announced United States Attorney Mike Stuart. The…
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,…
Charles City Nurse Anesthetist Sentenced to Nearly Three Years in Federal Prison for Drug Tampering and Diversion Scheme
Department of JusticeU.S. Attorney’s OfficeNorthern District of Iowa FOR IMMEDIATE RELEASEFriday, May 29, 2020 Replaced Dozens of Vials of Fentanyl with Saline in a Hospital’s Surgery and Birthing Centers A Charles City nurse anesthetist who secretly tampered with vials of fentanyl in a hospital’s surgery and birthing centers was sentenced today to nearly three years in…
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…