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Recall Observatory FDA recall evidence

Drug product

PREGABALIN, Capsule, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00071101268.

D-805-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
180 Capsules
Official record key
drug-enforcement:D-805-2014

Official wording

Reason: Labeling: Label Mixup: PREGABALIN, Capsule, 25 mg may have potentially been mislabeled as one of the following drugs: CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: W003713, EXP: 6/26/2014; glyBURIDE MICRONIZED, Tablet, 3 mg, NDC 00093803501, Pedigree: W003155, EXP: 6/13/2014.

Code information: PREGABALIN, Capsule, 25 mg has the following codes: Pedigree: W003777, EXP: 6/26/2014; Pedigree: W003121, EXP:6/13/2014.

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