Recalls / Class II
Class IID-0851-2021
Product
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
- Affected lot / code info
- Lot #: DN5396, EP9726, EK2417, Exp. Date August 2022
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Viatris
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 9,515 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-08-23
- FDA classified
- 2021-09-24
- Posted by FDA
- 2021-10-06
- Terminated
- 2022-09-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0851-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.