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Recall Observatory FDA recall evidence

Drug product

MAGNESIUM CHLORIDE, Tablet, 64 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 68585000575

D-733-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
720 Tablets
Official record key
drug-enforcement:D-733-2014

Official wording

Reason: Labeling:Label Mixup; MAGNESIUM CHLORIDE, Tablet, 64 mg may be potentially mislabeled as VITAMIN B COMPLEX W/C, Tablet, NDC 00904026013, Pedigree: AD52993_31, EXP: 5/17/2014; ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: W003526, EXP: 6/21/2014; NICOTINE POLACRILEX, LOZENGE, 2 mg, NDC 00135051001, Pedigree: W002766, EXP: 6/6/2014; THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedig

Code information: MAGNESIUM CHLORIDE, Tablet, 64 mg has the following codes Pedigree: AD52993_4, EXP: 5/17/2014; Pedigree: W003527, EXP: 6/21/2014; Pedigree: W002712, EXP: 6/6/2014; Pedigree: W003359, EXP: 6/19/2014; Pedigree: W003923, EXP: 6/28/2014.

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