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

DrugsSource: FDA (drug) · Date: 2026-09-09

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Mylan Pharmaceuticals Inc
Product
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 / hazard
Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide within the U.S
Recall initiated
2026-08-17
Code info
Lot #: 3225272, Exp. September 30, 2026
Product quantity
47,662 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Morgantown
State
WV
Country
United States
Event id
99653
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