Lyrica
FDA Recall NDC 0071-1012
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 2 recorded enforcement report(s) associated with Lyrica (NDC 0071-1012). A significant event, classified as Class II, was initiated on Jan 11, 2016 by Parke-davis Div Of Pfizer Inc. The reported reason for this action was: "FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Jan 11, 2016
Feb 10, 2016
30,672 bottles
Recall Profile & Regulatory Data
Event ID
73043
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Apr 24, 2017
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
Batch or Lot Expiration Information
Lot# : M07861, Exp 05/2018
Affected Packages Involved in this Recall
0071-1012-68Product
0071-1013-41Product
0071-1013-68Product
0071-1014-41Product
0071-1014-68Product
0071-1015-41Product
0071-1015-68Product
0071-1016-41Product
0071-1016-68Product
0071-1017-68Product
0071-1019-68Product
0071-1018-68Product
0071-1020-01Product
Class II Terminated
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Jan 11, 2016
Feb 10, 2016
116,400 bottles
Recall Profile & Regulatory Data
Event ID
73043
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Apr 24, 2017
Product Description
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
Batch or Lot Expiration Information
Lot# : M07862, Exp 05/2018; M07865, Exp 06/2018
Affected Packages Involved in this Recall
0071-1012-68Product
0071-1013-41Product
0071-1013-68Product
0071-1014-41Product
0071-1014-68Product
0071-1015-41Product
0071-1015-68Product
0071-1016-41Product
0071-1016-68Product
0071-1017-68Product
0071-1019-68Product
0071-1018-68Product
0071-1020-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
