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Recall Observatory FDA recall evidence

Drug product

MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64376081501

D-687-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
100 Chew Tablets
Official record key
drug-enforcement:D-687-2014

Official wording

Reason: Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F) may be potentially mislabeled as ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP, Capsule, 65 mg/100 mg/325 mg, NDC 44183044001, Pedigree: AD22858_1, EXP: 3/31/2014.

Code information: MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F) has the following code Pedigree: AD22609_7, EXP: 5/2/2014.

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