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Recall Observatory FDA recall evidence

Drug product

GLUCOSAMINE/CHONDROITIN Capsule, 500 mg/400 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 54458010022

D-616-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
60 Capsules
Official record key
drug-enforcement:D-616-2014

Official wording

Reason: Labeling:Label Mixup; GLUCOSAMINE/CHONDROITIN Capsule, 500 mg/400 mg may be potentially mislabeled as FEXOFENADINE HCL, Tablet, 60 mg, NDC 45802042578, Pedigree: AD60240_30, EXP: 5/22/2014.

Code information: GLUCOSAMINE/CHONDROITIN, Capsule, 500 mg/400 mg has the following code Pedigree: AD60240_33, EXP: 5/22/2014.

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