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Recall Observatory FDA recall evidence

Drug product

VENLAFAXINE HCL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093738301.

D-847-2014

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-847-2014

Official wording

Reason: Labeling: Label Mixup: VENLAFAXINE HCL, Tablet, 100 mg may have potentially was mislabeled as tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: AD73525_31, EXP: 5/30/2014; and may have potentially been mislabeled as one of the following drugs: methylPREDNISolone, Tablet, 4 mg, NDC 00603459321, Pedigree: AD32764_11, EXP: 3/31/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree:

Code information: VENLAFAXINE HCL, Tablet, 100 mg has the following codes: Pedigree: AD73525_37, EXP: 5/30/2014; Pedigree: AD42566_1, EXP: 5/14/2014; Pedigree: W002619, EXP: 6/4/2014.

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