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Recall Observatory FDA recall evidence

Drug product

LACTOBACILLUS Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 64980012950

D-700-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
1,249 Tablets
Official record key
drug-enforcement:D-700-2014

Official wording

Reason: Labeling: Label Mixup; LACTOBACILLUS Tablet may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 65162066850, Pedigree: AD62979_1, EXP: 5/23/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD62986_1, EXP: 5/23/2014; LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg), NDC 00054002025, Pedigree: AD21790_25, EXP: 5/1/2014; OMEGA-3 FATTY ACID, Capsule, 100

Code information: LACTOBACILLUS Tablet has the following codes Pedigree: AD62986_10, EXP: 5/23/2014; Pedigree: AD62992_1, EXP: 5/23/2014; Pedigree: AD22865_1, EXP: 5/2/2014; Pedigree: W003624, EXP: 1/31/2014; Pedigree: W003622, EXP: 6/25/2014; Pedigree: W003623, EXP: 10/31/2013.

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

Field note

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