Why it was recalled
Failed Dissolution Specification: Low out of specification dissolution results.
Product description
Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93
Lot numbers, UPCs & expiration codes
Lot #: 3089793, Exp. Date September 2020
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0155-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 18, 2019
- FDA report date
- Nov 6, 2019
- Quantity
- 4,272 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0155-2020, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 84039
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot #: 3089793, Exp. Date September 2020
- Postal code
- 26505-2730
- Report date
- Nov 6, 2019
- Product type
- Drugs
- Recall number
- D-0155-2020
- Classification
- Class II
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 4,272 bottles
- Termination date
- Apr 10, 2020
- Reason for recall
- Failed Dissolution Specification: Low out of specification dissolution results.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 18, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 28, 2019