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Recall Observatory FDA recall evidence

Drug product

LACTOBACILLUS GG Capsule, 15 Billion Cells, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 49100036374

D-581-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
630 Cells
Official record key
drug-enforcement:D-581-2014

Official wording

Reason: Labeling: Label Mixup; LACTOBACILLUS GG Capsule, 15 Billion Cells may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: W003356, EXP: 6/19/2014; ZONISAMIDE, Capsule, 100 mg, NDC 64679099001, Pedigree: W003786, EXP: 6/27/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: W003860, EXP: 6/27/2014.

Code information: LACTOBACILLUS GG, Capsule, 15 Billion Cells has the following codes Pedigree: W003357, EXP: 6/19/2014; Pedigree: W003787, EXP: 6/27/2014; Pedigree: W003869, EXP: 6/27/2014.

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