Medical Device and Pharmaceutical News
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AvKARE Recalls Atovaquone Oral Suspension
AvKARE Recalls Atovaquone Oral Suspension AvKARE, LLC has issued a voluntary recall of lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL due to potential Bacillus cereus contamination found during stability testing at a third-party lab. The affected...
FDA Warns of Risks with OTC Pain Relief Products
The U.S. Food and Drug Administration (FDA) has issued a stern warning to consumers regarding the use of certain over-the-counter analgesic (pain relief) products intended for topical use before, during, or after various cosmetic procedures like microdermabrasion,...
FDA Approves Treatment for Platinum-Resistant Ovarian Cancer
In a significant development for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, on March 22, 2024 the Food and Drug Administration (FDA) granted approval for mirvetuximab soravtansine-gynx, marketed as Elahere by...
Urgent Recall Alert for Methocarbamol Injection by Eugia US LLC
Attention Consumers, Healthcare Providers, and Distributors: Eugia US LLC, formerly known as AuroMedics Pharma LLC, announced a voluntary recall on March 28, 2024 of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) 10mL Single Dose Vial....
Amneal Recalls Vancomycin Hydrochloride Oral Solution
Some bottles may be super potent Attention Patients, Health Professionals, and Pharmacies: Amneal Pharmaceuticals issued a safety notice on March 27 for a recall of specific lots of Vancomycin Hydrochloride for Oral Solution USP, 250 mg/ 5mL. This recall has been...
FDA Proposes Ban of Certain ESDs
Ban would affect devices used to treat aggressive/self-injurious behavior In a landmark move, the U.S. Food and Drug Administration (FDA) has proposed a ban on electrical stimulation devices (ESDs) designed to reduce or stop self-injurious or aggressive behavior. This...
FDA Approves Thoracic Stent Graft System
FDA Approves RelayPro Thoracic Stent Graft System for Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers Treatment The United States Food and Drug Administration (FDA) on March 7, 2023 approved the RelayPro Thoracic Stent Graft System, a new medical...
Abbott Safety Alert for Freestyle Libre Systems
Misuse may cause battery overheating and incorrect readings The FDA has issued a safety notification regarding the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems. The notification warns users of the potential for...
Camber Recalls Atovaquone Oral Suspension USP
Camber Recalls Atovaquone Oral Suspension USP for Potential Contamination Camber Pharmaceuticals Inc. recently issued a voluntary nationwide recall of Atovaquone Oral Suspension USP due to potential contamination. The recall was announced by the U.S. Food and Drug...
Prodigy Proclaim Spinal Cord Stimulation Systems
Significant advancement for chronic pain treatment On February 15, 2023, the U.S. Food and Drug Administration (FDA) announced the approval of the Prodigy Proclaim and Proclaim XR Spinal Cord Stimulation (SCS) systems. This approval marks a significant step forward in...