PlainRecordsFDA · Drug recall
Prasugrel HCI…
- Date
- Sept. 9, 2026
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing
- Filed by
- Golden State Medical Supply Inc.
- Product
- Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30.
- Reason
- Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
- Distribution pattern
- US Nationwide.
- Quantity
- 6791 30-count bottles
- Codes and lots
- Lot # GS062298, Exp Date: 09/30/ 2026.
- Recall started
- Aug. 21, 2026
- Recall number
- D-0847-2026
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement report, recall number D-0847-2026. The agency record governs; check it and the company before acting.