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Amneal Pharmaceuticals, LLC. Issues a Nationwide Voluntary Recall of Vancomycin Hydrochloride for Oral Solution USP, 250mg/5mL, Due to the Potential for Some Bottles to be Super Potent Which May be Harmful

by | Aug 12, 2025 | News

Summary Company Announcement Date: March 27, 2024 FDA Publish Date: March 27, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Super potent due to bottles being overfilled Company Name: Amneal Pharmaceuticals, LLC. Brand Name: Product...

ICH M13B Webinar

by | Aug 12, 2025 | News

On This Page Date: September 11, 2025 Time: 12:00 p.m. – 2:00 p.m. ET This webinar will provide an in-depth look at the draft ICH M13B guideline titled “Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver”...

Max Mobility / Permobil Announces Worldwide Expanded Recall and Removal of all SpeedControl Dials from the Market Due to Intermittent Cable Connection Concerns of the Dial with the SmartDrive MX2+ Motor. Users Must Use an Alternate Control Method for their SmartDrive MX2+ Power Assist Device.

by | Aug 12, 2025 | News

Summary Company Announcement Date: August 12, 2025 FDA Publish Date: August 12, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Due to potential safety and performance concerns Company Name: Max Mobility, LLC. Brand Name: Product...

State of the Science for Bioaccumulation

by | Aug 12, 2025 | News

On This Page The Eco-NAMS webinar series is co-organized by the U.S. Food and Drug Administration, U.S. Environmental Protection Agency, European Medicines Agency, Health and Environmental Sciences Institute, National Institute for Environmental Studies (Japan), and...

Confer With – 707691 – 08/01/2025

by | Aug 12, 2025 | News

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Serge Milbank Confer With 81 Rivington StLondonEC2A 3AYUnited Kingdom getintouch@conferwith.io Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTERAugust 1,...