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Recall Observatory FDA recall evidence

Drug product

PREGABALIN, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00071101768.

D-806-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
540 Capsules
Official record key
drug-enforcement:D-806-2014

Official wording

Reason: Labeling: Label Mixup: PREGABALIN, Capsule, 200 mg may have potentially been mislabeled as one of the following drugs: LOSARTAN POTASSIUM, Tablet, 50 mg, NDC 00781570192, Pedigree: AD21965_10, EXP: 5/1/2014; CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: AD30180_25, EXP: 5/9/2014; clonazePAM, Tablet, 0.25 mg (1/2 of 0.5 mg), NDC 00093083201, Pedigree: AD73518_1, EXP: 5/31/2014; OM

Code information: Labeling: Label Mixup: PREGABALIN, Capsule, 200 mg has the following codes: Pedigree: AD21787_1, EXP: 5/1/2014; Pedigree: AD30024_1, EXP: 5/9/2014; Pedigree: AD73518_4, EXP: 5/31/2014; Pedigree W002759, EXP: 6/6/2014; Pedigree: W003397, EXP: 6/19/2014; Pedigree: W003398, EXP: 6/19/2014.

Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled