MHRA CEO Lawrence Tallon welcomes Life Sciences Sector Plan
The Life Sciences Sector plan was released today (16 July 2025)
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Clinical investigations for medical devices
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
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Krasniy Oktyabr Inc. USA Issues Alert on Eviscerate Dry Salted Vobla “Aral Silver”
KRASNIY OKTYABR INC. USA. of BROOKLYN, NY, is recalling its “ARAL SILVER VOBLA” brand “ARAL”, because the product was found to be uneviscerated. -
Update – Sandoz Inc. Issues Voluntary Nationwide Recall Expansion of One Additional Lot of Cefazolin for Injection Due to Vials Being Potentially Mislabeled as Penicillin G Potassium for Injection
Sandoz, Inc. (“Sandoz”) is initiating a voluntary nationwide recall expansion of one additional lot of Cefazolin for Injection, USP, 1 gram per vial. The lot is being recalled due to a customer complaint indicating that four (4) vials incorrectly labelled as Penicillin G Potassium for Injection, USP -
Safety and Availability Concerns with VasoView HemoPro Endoscopic Vessel Harvesting Systems – Letter to Health Care Providers
The FDA is alerting health care providers to the recall of certain VasoView HemoPro devices due to risk of silicone detachment during use, and supply concerns. -
Early Alert: Infusion Set Performance Issue from BD
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. -
FDA and Kratom
Kratom is not lawfully marketed in the U.S. as a drug product, a dietary supplement, or a food additive in conventional food. -
Mark J. Savant, M.D./San Francisco Research Institute – 712306 – 06/26/2025
Clinical Investigator -
Daewoo Pharmaceutical Co., Ltd. – 706371 – 07/02/2025
CGMP/Finished Pharmaceuticals/Adulterated -
Scope Health Inc – 695085 – 07/09/2025
Unapproved New Drugs/Misbranded -
Thea Pharma, Inc. – 712416 – 07/09/2025
Unapproved New Drugs/Misbranded -
Revitalize Energy, Inc. – 712417 – 07/09/2025
Unapproved New Drugs/Misbranded