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Recall Observatory FDA recall evidence

Drug product

VENLAFAXINE HCL, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093019901.

D-822-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
300 Tablets
Official record key
drug-enforcement:D-822-2014

Official wording

Reason: Labeling: Label Mixup: VENLAFAXINE HCL, Tablet, 25 mg may have potentially been mislabeled as one of the following drugs: sitaGLIPtin PHOSPHATE, Tablet, 50 mg, NDC 00006011231, Pedigree: W002824, EXP: 6/7/2014; LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: W003847, EXP: 6/27/2014; LITHIUM CARBONATE ER, Tablet, 450 mg, NDC 00054002025, Pedigree: AD62796_1, EXP: 5/22/2014.

Code information: VENLAFAXINE HCL, Tablet, 25 mg has the following codes: Pedigree: W002825, EXP: 12/31/2013; Pedigree: W003860, EXP: 6/27/2014; Pedigree: AD62796_4, 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