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Recall Observatory FDA recall evidence

Drug product

TRIHEXYPHENIDYL HCL, Tablet, 1 mg (1/2 of 2 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00591533501.

D-974-2014

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-974-2014

Official wording

Reason: Labeling: Label Mixup:TRIHEXYPHENIDYL HCL, Tablet, 1 mg (1/2 of 2 mg) may have potentially been mislabeled as the following drug: PERPHENAZINE, Tablet, 16 mg, NDC 00781104901, Pedigree: AD73525_22, EXP: 5/30/2014.

Code information: TRIHEXYPHENIDYL HCL, Tablet, 1 mg (1/2 of 2 mg) has the following codes: Pedigree: AD73525_34, EXP: 5/30/2014.

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