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Medicine / D-0839-2026

U.S. Food and Drug AdministrationD-0839-2026

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

Class II Distributed nationwide or U.S.-wide Status: Ongoing

What was recalled

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.

Recalling firm

Mylan Pharmaceuticals Inc

Reason for recall

Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria

Where it went

Nationwide within the U.S

Shown as U.S. Food and Drug Administration published it (shortened where marked …). Recall Shelf does not change recall facts and is not affiliated with the agency.