Why it was recalled
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Product description
Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1013-68
Lot numbers, UPCs & expiration codes
Lot #: M07861, Exp 05/2018
Where it was sold
Nationwide and Puerto Rico
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-0648-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 11, 2016
- FDA report date
- Feb 10, 2016
- Quantity
- 30,672 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0648-2016, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 73043
- Address
- 235 East 42nd Street
- Code information
- Lot #: M07861, Exp 05/2018
- Postal code
- 10017-5703
- Report date
- Feb 10, 2016
- Product type
- Drugs
- Recall number
- D-0648-2016
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 30,672 bottles
- Termination date
- Apr 24, 2017
- Reason for recall
- FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1013-68
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jan 11, 2016
- Initial firm notification
- Letter
- Center classification date
- Feb 1, 2016