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Recall Observatory FDA recall evidence

Drug product

PYRIDOXINE HCL, Tablet, 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536440901.

D-942-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65690
Status
Terminated
Classification
Class II
Quantity
299 Tablets
Official record key
drug-enforcement:D-942-2014

Official wording

Reason: Labeling: Label Mixup: PYRIDOXINE HCL, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: AD73627_29, EXP: 5/30/2014; COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: W003871, EXP: 6/27/2014; VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 0 mg, NDC 40985022251, Pedigree: AD76686_1, EXP: 5/31/201

Code information: PYRIDOXINE HCL, Tablet, 100 mg has the following codes: Pedigree: AD73627_32, EXP: 5/30/2014; Pedigree: W003872, EXP: 6/27/2014; Pedigree: AD76686_4, EXP: 5/31/2014.

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