MYLAN PHARMACEUTICALS INC: Drug Recall

Recall #D-0280-2025 · 02/25/2025

Class II: Risk

Recall Details

Recall Number: D-0280-2025
Classification: Class II
Product Type: Drug
Recalling Firm: MYLAN PHARMACEUTICALS INC
Status: Ongoing
Date Initiated: 02/25/2025
Location: Morgantown, WV, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Reason for Recall

Failed Dissolution Specifications - low dissolution results

Product Description

Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93

Distribution Pattern

US Nationwide.

Other Recalls by MYLAN PHARMACEUTICALS INC

Class I: Dangerous 07/05/2022

Labeling: Missing label: Label missing from some prefilled pens.
Class I: Dangerous 04/12/2022

Labeling: Missing label on the vial
Class II: Risk 04/07/2022

Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Class II: Risk 04/01/2022

Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.
Class II: Risk 01/21/2022

cGMP deficiencies

View all recalls by MYLAN PHARMACEUTICALS INC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.