Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan…
Official notice from a government agency or its published feed.
Reason: Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Nationwide within the U.S
Hazard: Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
View the FDA enforcement report ↗ ← All reports