Recall Enforment Report D-0648-2016

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Pfizer Inc., originally initiated on 01-11-2016 for the 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 The product was recalled due to failed tablet/capsule specifications: firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0648-201601-11-201602-10-2016Class II30,672 bottlesLyrica (pregabalin) capsules, 50 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1013-68FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.Terminated
D-0649-201601-11-201602-10-2016Class II116,400 bottlesLyrica (pregabalin) capsules, 75 mg, 90-count bottle, Rx only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, NDC 0071-1014-68FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0071-1012Lyrica PregabalinCapsuleOralParke-davis Div Of Pfizer IncHuman Prescription Drug
0071-1013Lyrica PregabalinCapsuleOralParke-davis Div Of Pfizer IncHuman Prescription Drug
0071-1014Lyrica PregabalinCapsuleOralParke-davis Div Of Pfizer IncHuman Prescription Drug
0071-1015Lyrica PregabalinCapsuleOralParke-davis Div Of Pfizer IncHuman Prescription Drug
0071-1016Lyrica PregabalinCapsuleOralParke-davis Div Of Pfizer IncHuman Prescription Drug
0071-1017Lyrica PregabalinCapsuleOralParke-davis Div Of Pfizer IncHuman Prescription Drug
0071-1018Lyrica PregabalinCapsuleOralParke-davis Div Of Pfizer IncHuman Prescription Drug
0071-1019Lyrica PregabalinCapsuleOralParke-davis Div Of Pfizer IncHuman Prescription Drug
0071-1020Lyrica PregabalinSolutionOralParke-davis Div Of Pfizer IncHuman Prescription Drug