Mylan Pharmaceuticals Inc. recalls Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.…
- Recall date
- October 18, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0155-2020
- FDA classification
- Class II
- Brand / firm
- Mylan Pharmaceuticals Inc.
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Failed Dissolution Specification: Low out of specification dissolution results.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93
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