FDA-Drug2019-11-06Class II

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

Mylan Pharmaceuticals Inc.
Hazard

Failed Dissolution Specification: Low out of specification dissolution results.

Sold states
Nationwide within the United States
Affected count
4,272 bottles
Manufactured in
781 Chestnut Ridge Rd, Morgantown, WV, United States
Products
Prasugrel Tablets 5 mg, 30-count bottles, 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-0155-2020

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