FDAFDA · Food and drugs·Recall number D-0155-2020
Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93
Published November 6, 2019 · Recall initiated: October 18, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specification: Low out of specification dissolution results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PRASUGREL
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Distributor
- Nationwide within the United States
- UPC
- 0303785185932
- Lot
- Lot #: 3089793, Exp. Date September 2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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