Recalls / Class II
Class IID-0287-2025
Product
PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30
- Brand name
- Prasugrel
- Generic name
- Prasugrel
- Active ingredient
- Prasugrel Hydrochloride
- Route
- Oral
- NDCs
- 51407-444, 51407-445
- FDA application
- ANDA205927
- Affected lot / code info
- Lot no's: GS059908, GS060228, GS060709, GS061233, GS061704, GS062158, GS062405, Exp.: 04/30/2026
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Golden State Medical Supply Inc.
- Manufacturer
- Golden State Medical Supply, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, N/A, Camarillo, California 93012-8601
Distribution
- Quantity
- 2,601 30-count bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2025-03-05
- FDA classified
- 2025-03-20
- Posted by FDA
- 2025-03-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0287-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.