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Recall Observatory FDA recall evidence

Drug product

CRANBERRY EXTRACT/VITAMIN C Capsule, 450 mg/125 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 31604014271

D-543-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
546 Capsules
Official record key
drug-enforcement:D-543-2014

Official wording

Reason: Labeling: Label Mixup; CRANBERRY EXTRACT/VITAMIN C Capsule, 450 mg/125 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00536406001, Pedigree: W002653, EXP: 6/5/2014; MODAFINIL, Tablet, 200 mg, NDC 00603466216, Pedigree: W003779, EXP: 6/26/2014; NIACIN ER, Tablet, 500 mg, NDC 00074307490, Pedigree: W003739, EXP: 6/26/2014; GLUCOSAMINE/CHONDROITIN, Capsule, 500 mg/40

Code information: CRANBERRY EXTRACT/VITAMIN C Capsule, 450 mg/125 mg has the following codes Pedigree: W002692, EXP: 6/5/2014; Pedigree: W003715, EXP: 6/26/2014; Pedigree: W003716, EXP: 6/26/2014; Pedigree: AD60240_11, EXP: 5/22/2014; Pedigree: W002693, EXP: 6/5/2014; Pedigree: AD46257_13, EXP: 5/15/2014.

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