Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorpora…
Official notice from a government agency or its published feed.
Reason: Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalledThe maker or a government agency pulled this product. Check the model or lot number and stop using it until it's fixed or refunded. due to failed dissolution
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · US Nationwide.
Hazard: Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
View the FDA enforcement report ↗ ← All reports