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Recall Observatory FDA recall evidence

Drug product

amLODIPine BESYLATE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093716798.

D-843-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
90 Tablets
Official record key
drug-enforcement:D-843-2014

Official wording

Reason: Labeling: Label Mixup: amLODIPine BESYLATE, Tablet, 5 mg may have potentially been mislabeled as the following drug: CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: W002839, EXP: 6/7/2014.

Code information: amLODIPine BESYLATE, Tablet, 5 mg has the following codes: Pedigree: W002840, EXP: 6/7/2014.

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