FDA recall D-0847-2026

Golden State Medical Supply Inc. · Class II · drug

Product

Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30.

Reason for recall

Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution

Distribution

US Nationwide.

Key facts

Status
Ongoing
Initiation date
2026-08-21
Report date
2026-09-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Camarillo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0847-2026