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Recall Observatory FDA recall evidence

Drug product

GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904548152

D-481-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
180 Capsules
Official record key
drug-enforcement:D-481-2014

Official wording

Reason: Labeling: Label Mixup; GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 mg may be potentially mislabeled as GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: AD22865_4, EXP: 5/2/2014; PREGABALIN, Capsule, 25 mg, NDC 00071101268, Pedigree: W003121, EXP: 6/13/2014; MULTIVITAMIN/MULTIMINERAL, Chew Tablet, NDC 00536344308, Pedigree: AD73521_10, EXP: 5/30/2014.

Code information: GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 mg has the following codes Pedigree: AD21846_14, EXP: 5/1/2014; Pedigree: W003316, EXP: 6/18/2014; Pedigree: AD73521_16, 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