FDA Drug Safety Information for January 31, 2025

Jan 312025
 
Date
Brand Name(s)
Description
Type
Reason
Company 
1/31/2025 Alvogen Fentanyl Transdermal System 25 mcg/h transdermal patches Drugs There is potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch Alvogen, Inc.

FDA Drug Safety Information for January 30, 2025

Jan 302025
 

Date Brand Name(s) Description Type Reason Company  1/30/2025 Olympus MAJ-891 endoscope accessory Medical Devices Risk of device contamination that may result from improper reprocessing. Olympus

FDA Drug Safety Information for January 24, 2025

Jan 242025
 

Date Brand Name(s) Description Type Reason Company  01/24/2025 Provepharm Inc. Phenylephrine hydrochloride Injection, USP, 10 mg/ mL Drugs Device & Drug Safety – Potential Foreign

FDA Drug Safety Information for January 17, 2025

Jan 172025
 

Date Brand Name(s) Description Type Reason Company  01/17/2025 Max Mobility/Permobil Speed Control Dial Component Medical Devices Due to potential safety and performance concerns. Max Mobility,

FDA Drug Safety Information for December 24, 2024

Dec 242024
 

Date Brand Name(s) Description Type Reason Company  12/24/2024 Astellas Tacrolimus and Tacrolimus Extended-Release capsules Drugs Bottles may contain empty capsules. Astellas Pharma US, Inc.

FDA Drug Safety Information for December 20, 2024

Dec 202024
 

Date Brand Name(s) Description Type Reason Company  12/20/2024 Par Pharmaceutical Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP) Drugs Product is an unapproved drug. Endo, Inc.

FDA Drug Safety Information for November 19, 2024

Nov 192024
 

Date Brand Name(s) Description Type Reason Company  11/19/2024 Par Pharmaceutical Clonazepam Orally Disintegrating Tablets, USP (C-IV) Drugs Mislabeled with the incorrect strength on the carton

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