Recalls / Class II
Class IID-0155-2020
Product
Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93
- Brand name
- Prasugrel
- Generic name
- Prasugrel
- Active ingredient
- Prasugrel Hydrochloride
- Route
- Oral
- NDCs
- 0378-5185, 0378-5186
- FDA application
- ANDA205927
- Affected lot / code info
- Lot #: 3089793, Exp. Date September 2020
Why it was recalled
Failed Dissolution Specification: Low out of specification dissolution results.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 4,272 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-10-18
- FDA classified
- 2019-10-28
- Posted by FDA
- 2019-11-06
- Terminated
- 2020-04-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0155-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.