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Recall Observatory FDA recall evidence

Drug product

VALSARTAN, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078035834.

D-815-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
1440 Tablets
Official record key
drug-enforcement:D-815-2014

Official wording

Reason: Labeling: Label Mixup: VALSARTAN, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: TEMAZEPAM, Capsule, 7.5 mg, NDC 00378311001, Pedigree: AD49418_1, EXP: 5/17/2014; VALSARTAN, Tablet, 320 mg, NDC 00078036034, Pedigree: AD65475_7, EXP: 5/28/2014; ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC 62175010701, Pedigree: AD67989_10, EXP: 5/28/2014; CHOLECALCIFEROL, Tablet

Code information: VALSARTAN, Tablet, 80 mg has the following codes: Pedigree: AD52372_4, EXP: 5/17/2014; Pedigree: AD65475_10, EXP: 5/28/2014; Pedigree: AD68025_1, EXP: 5/28/2014; Pedigree: AD70585_1, EXP: 5/29/2014; Pedigree: W002768, EXP: 6/10/2014; Pedigree: W003535, EXP: 6/21/2014; Pedigree: AD62995_4, EXP: 5/28/2014; Pedigree: AD73597_1, EXP: 5/31/2014; Pedigree: W002616, 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