FDA recall D-0649-2016

Pfizer Inc. · Class II · drug

Product

Lyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1014-68

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.

Distribution

Nationwide and Puerto Rico

Key facts

Status
Terminated
Initiation date
2016-01-11
Report date
2016-02-10
Termination date
2017-04-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0649-2016