foundmatterdb

Field reports on stuff that let you down

FDA recallMedicationsClass II· Mylan Pharmaceuticals Inc

Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan…

Official notice from a government agency or its published feed.

Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.
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

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