Official recall notice
FDA DrugClass IINotable
FDA Recall: Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camari
- Recall date
- 2026-09-09
- Category
- Drug
- FDA class
- Class II
Why it was recalled
Hazard
Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
Product description
Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
Affected products
Lot # GS062298, Exp Date: 09/30/ 2026.