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Recall Observatory FDA recall evidence

Drug product

PERPHENAZINE, Tablet, 16 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781104901.

D-998-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
1200 Tablets
Official record key
drug-enforcement:D-998-2014

Official wording

Reason: Labeling: Label Mixup: PERPHENAZINE, Tablet, 16 mg may have potentially been mislabeled as one of the following drugs: LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: AD21790_28, EXP: 5/1/2014; LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: W002730, EXP: 6/6/2014; RALTEGRAVIR, Tablet, 400 mg, NDC 00006022761, Pedigree: W003680, EXP: 6/25/2014; VENLAFAXINE HCL

Code information: PERPHENAZINE, Tablet, 16 mg has the following codes: Pedigree: AD21790_31, EXP: 5/1/2014; Pedigree: W002731, EXP: 6/6/2014; Pedigree: W003682, EXP: 6/25/2014; Pedigree: AD73525_22, EXP: 5/30/2014; Pedigree: W003328, EXP: 6/19/2014.

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