Class II · Moderate risk Ongoing
PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30
Reason Failed Dissolution Specifications
Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specification: Low out of specification dissolution results.
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
- Recalling firm
- Mylan Pharmaceuticals Inc.
- NDC code
- 0378-5185-93
- Origin
- WV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0155-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Prasugrel recalls
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Class II · Moderate risk Ongoing
Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505…
Reason Failed Dissolution Specifications - low dissolution results
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