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Recall Observatory FDA recall evidence

Drug product

LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00591024001.

D-960-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
200 Tablets
Official record key
drug-enforcement:D-960-2014

Official wording

Reason: Labeling: Label Mixup: LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg) may have potentially been mislabeled as the following drug: traMADol HCl, Tablet, 25 mg (1/2 of 50 mg), NDC 57664037708, Pedigree: AD60272_92, EXP: 5/22/2014.

Code information: LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg) has the following codes: Pedigree: AD60243_1, EXP: 5/22/2014.

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