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Recall Observatory FDA recall evidence

Drug product

PYRIDOXINE HCL Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 51645090901

D-599-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
600 Tablets
Official record key
drug-enforcement:D-599-2014

Official wording

Reason: Labeling: Label Mixup; PYRIDOXINE HCL Tablet, 50 mg may be potentially mislabeled as CALCIUM CITRATE, Tablet, 950 mg (200 mg Elem Ca), NDC 00904506260, Pedigree: W002699, EXP: 6/5/2014; MULTIVITAMIN/MULTIMINERAL W/IRON, Chew Tablet, NDC 00536781601, Pedigree: W003018, EXP: 6/12/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003705, EXP: 6/25/2014; LACTASE ENZYME, Tab

Code information: PYRIDOXINE HCL, Tablet, 50 mg has the following codes Pedigree: W002697, EXP: 6/5/2014; Pedigree: W003019, EXP: 6/12/2014; Pedigree: W003718, EXP: 6/26/2014; Pedigree: AD46257_25, EXP: 5/15/2014; Pedigree: AD73521_25, 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