FDA-Drug2025-03-26Class II

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

MYLAN PHARMACEUTICALS INC
Hazard

Failed Dissolution Specifications - low dissolution results

Sold states
US Nationwide.
Affected count
N/A
Manufactured in
1311 Pineview Dr, N/A, Morgantown, WV, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0280-2025

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