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Recall Observatory FDA recall evidence

Drug product

tiZANidine HCl, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378072219.

D-893-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
150 Tablets
Official record key
drug-enforcement:D-893-2014

Official wording

Reason: Labeling: Label Mixup: tiZANidine HCl, Tablet, 2 mg may have potentially been mislabeled as the following drug: NIACIN TR, Tablet, 500 mg, NDC 00904434260, Pedigree: W002969, EXP: 6/11/2014.

Code information: tiZANidine HCl, Tablet, 2 mg has the following codes: Pedigree: W002975, EXP: 6/11/2014.

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