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Recall Observatory FDA recall evidence

Drug product

LACTOBACILLUS GG Capsule, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49100036374

D-579-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
1,970 Capsules
Official record key
drug-enforcement:D-579-2014

Official wording

Reason: Labeling: Label Mixup; LACTOBACILLUS GG Capsule may be potentially mislabeled as VITAMIN B COMPLEX W/C, Capsule, NDC 54629008001, Pedigree: AD39560_4, EXP: 5/13/2014; DOCUSATE SODIUM, Capsule, 50 mg, NDC 67618010060, Pedigree: AD65457_13, EXP: 5/24/2014; VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001, Pedigree: AD70655_17, EXP: 5/28/2014; TACROLIMUS, Capsule, 1 mg, NDC 00781210

Code information: LACTOBACILLUS GG, Capsule has the following codes Pedigree: AD39588_4, EXP: 5/13/2014 Pedigree: AD65457_16, EXP: 5/24/2014 Pedigree: AD70655_8, EXP: 5/29/2014 Pedigree: AD73627_17, EXP: 5/30/2014 Pedigree: W003051, EXP: 6/12/2014 Pedigree: W003216, EXP: 6/14/2014 Pedigree: AD42584_12, EXP: 5/14/2014 Pedigree: AD46300_11, EXP: 5/15/2014 Pedigree: W002968, EXP: 6/11/2014 Pedigree: AD68019_1, EXP: 5/28/2014 Pedigree: W003172, EXP: 6/13/2014 Pedigree: W003173, EXP: 6/13/2014

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