Why it was recalled
Failed Dissolution Specifications
Product description
Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx only, Distributed by Parke-Davis Division of Pfizer Inc., NY, NY 10017, NDC 0071-1029-01
Lot numbers, UPCs & expiration codes
Lot #: DN5396, EP9726, EK2417, Exp. Date August 2022
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-0851-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 23, 2021
- FDA report date
- Oct 6, 2021
- Quantity
- 9,515 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Viatris
Original FDA data
Every field from FDA enforcement report D-0851-2021, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 88542
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot #: DN5396, EP9726, EK2417, Exp. Date August 2022
- Postal code
- 26505-2730
- Report date
- Oct 6, 2021
- Product type
- Drugs
- Recall number
- D-0851-2021
- Classification
- Class II
- Recalling firm
- Viatris
- Product quantity
- 9,515 bottles
- Termination date
- Sep 7, 2022
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx only, Distributed by Parke-Davis Division of Pfizer Inc., NY, NY 10017, NDC 0071-1029-01
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Aug 23, 2021
- Initial firm notification
- Letter
- Center classification date
- Sep 24, 2021