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Recall Observatory FDA recall evidence

Drug product

MULTIVITAMIN/MULTIMINERAL LOW IRON Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64376081601

D-688-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
400 Tablets
Official record key
drug-enforcement:D-688-2014

Official wording

Reason: Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL LOW IRON Tablet may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00527134601, Pedigree: AD60272_22, EXP: 5/22/2014; ATORVASTATIN CALCIUM, Tablet, 80 mg, NDC 00378212277, Pedigree: AD73627_1, EXP: 5/30/2014; MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 37205018581, Pedigree: W002513, EXP: 6/3/2014.

Code information: MULTIVITAMIN/MULTIMINERAL LOW IRON Tablet has the following codes Pedigree: AD60272_31, EXP: 5/22/2014; Pedigree: AD73627_8, EXP: 5/30/2014; Pedigree: W002507, EXP: 6/3/2014.

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