Recalls / Class II
Class IID-0648-2016
Product
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
- Brand name
- Lyrica
- Generic name
- Pregabalin
- Active ingredient
- Pregabalin
- Route
- Oral
- NDCs
- 0071-1014, 0071-1012, 0071-1013, 0071-1015, 0071-1016, 0071-1017, 0071-1019, 0071-1018, 0071-1020
- FDA application
- NDA021446
- Affected lot / code info
- Lot #: M07861, Exp 05/2018
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.
Recalling firm
- Firm
- Pfizer Inc.
- Manufacturer
- Parke-Davis Div of Pfizer Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 30,672 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-01-11
- FDA classified
- 2016-02-01
- Posted by FDA
- 2016-02-10
- Terminated
- 2017-04-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0648-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.