Drug product
PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30
D-0287-2025
Product summary
- Event
- Event 96441
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,601 30-count bottles
- Official record key
drug-enforcement:D-0287-2025
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot no's: GS059908, GS060228, GS060709, GS061233, GS061704, GS062158, GS062405, Exp.: 04/30/2026
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications