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Recall Observatory FDA recall evidence

Drug product

MULTIVITAMIN/ MULTIMINERAL/ LUTEIN Capsule, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 24208063210

D-535-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
204 Capsules
Official record key
drug-enforcement:D-535-2014

Official wording

Reason: Labeling: Label Mixup; MULTIVITAMIN/ MULTIMINERAL/ LUTEIN Capsule may be potentially mislabeled as CAFFEINE, Tablet, 200 mg, NDC 24385060173, Pedigree: AD21846_37, EXP: 5/1/2014; CAFFEINE, Tablet, 200 mg, NDC 24385060173, Pedigree: AD60240_42, EXP: 5/22/2014; CAFFEINE, Tablet, 200 mg, NDC 24385060173, Pedigree: W003024, EXP: 6/12/2014; MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD73

Code information: MULTIVITAMIN/ MULTIMINERAL/ LUTEIN Capsule has the following codes Pedigree: AD21846_40, EXP: 5/2/2014; Pedigree: AD60240_45, EXP: 5/22/2014; Pedigree: W003025, EXP: 6/12/2014; Pedigree: AD73521_37, EXP: 5/30/2014.

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