FDA Recall D-0287-2025

Golden State Medical Supply Inc. · Camarillo, CA

Class II Ongoing 435 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30

Lot / code: Lot no's: GS059908, GS060228, GS060709, GS061233, GS061704, GS062158, GS062405, Exp.: 04/30/2026

Quantity: 2,601 30-count bottles

Reason for recall

Failed Dissolution Specifications

Recall record

Recall number: D-0287-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S. Nationwide
Recall initiated: 2025-03-05
Classified by FDA Center: 2025-03-20
FDA published: 2025-03-26
Recalling firm: Golden State Medical Supply Inc.
Firm location: Camarillo, CA

Drug identification

Brand name(s): PRASUGREL
Generic name(s): PRASUGREL
Manufacturer(s): Golden State Medical Supply, Inc.
NDC(s): 51407-444, 51407-445
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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