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Recall Observatory FDA recall evidence

Drug 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

D-0648-2016

January 11, 2016

Class II

Product summary

Firm
Pfizer Inc.
Event
Event 73043
Status
Terminated
Classification
Class II
Quantity
30,672 bottles
Official record key
drug-enforcement:D-0648-2016

Official wording

Reason: FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.

Code information: Lot #: M07861, Exp 05/2018

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.