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Recall Observatory FDA recall evidence

Drug product

NICOTINE POLACRILEX, LOZENGE, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00135051001.

D-862-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
1216 Lozenges
Official record key
drug-enforcement:D-862-2014

Official wording

Reason: Labeling: Label Mixup: NICOTINE POLACRILEX, LOZENGE, 2 mg may have potentially been mislabeled as one of the following drugs: ESTRADIOL, Tablet, 0.5 mg, NDC 00555089902, Pedigree: AD30993_11, EXP: 5/9/2014; ACAMPROSATE CALCIUM DR, Tablet, 333 mg, NDC 00456333001, Pedigree: W002973, EXP: 6/11/2014; CALCITRIOL, Capsule, 0.5 mcg, NDC 63304024001, Pedigree: W003730, EXP: 6/26/2014; ESZOPICLONE, T

Code information: NICOTINE POLACRILEX, LOZENGE, 2 mg has the following codes: Pedigree: AD32973_7, EXP: 5/9/2014; Pedigree: W002974, EXP: 6/11/2014; Pedigree: W003749, EXP: 6/26/2014; Pedigree: W002766, EXP: 6/6/2014; Pedigree: AD21858_1, EXP: 5/1/2014; Pedigree: AD46333_10, EXP: 5/16/2014.

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