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Recall Observatory FDA recall evidence

Drug product

MULTIVITAMIN/MULTIMINERAL Chew Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 58914001460

D-638-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
180 Chew Tablets
Official record key
drug-enforcement:D-638-2014

Official wording

Reason: Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL Chew Tablet may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg), NDC 00527134101, Pedigree: AD30140_40, EXP: 5/7/2014; LACTOBACILLUS ACIDOPHILUS, Capsule, 500 Million CFU, NDC 43292050022, Pedigree: AD30028_10, EXP: 5/7/2014.

Code information: MULTIVITAMIN/MULTIMINERAL, Chew Tablet has the following codes Pedigree: AD30180_10, EXP: 5/9/2014; Pedigree: AD32325_1, EXP: 5/9/2014.

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