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Recall Observatory FDA recall evidence

Drug product

VENLAFAXINE HCL ER, Capsule, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093738656.

D-848-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
120 Capsules
Official record key
drug-enforcement:D-848-2014

Official wording

Reason: Labeling: Label Mixup: VENLAFAXINE HCL ER, Capsule, 150 mg may have potentially been mislabeled as one of the following drugs: SOTALOL HCL, Tablet, 80 mg, NDC 00093106101, Pedigree: AD30993_17, EXP: 5/9/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: W003075, EXP: 6/12/2014; LANTHANUM CARBONATE, CHEW Tablet, 500 mg, NDC 4092025290, Pedigree: W003410, EXP: 6/19/2014.

Code information: VENLAFAXINE HCL ER, Capsule, 150 mg has the following codes: Pedigree: AD30993_20, EXP: 5/9/2014; Pedigree: W003084, EXP: 6/12/2014; Pedigree: W003414, 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