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Recall Observatory FDA recall evidence

Drug product

MAGNESIUM CHLORIDE DR, Tablet, 64 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904791152

D-492-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
180 Tablets
Official record key
drug-enforcement:D-492-2014

Official wording

Reason: Labeling: Label Mixup; MAGNESIUM CHLORIDE DR, Tablet, 64 mg may be potentially mislabeled as SELEGILINE HCL, Capsule, 5 mg, NDC 67253070006, Pedigree: AD54549_19, EXP: 5/20/2014; PHOSPHORUS, Tablet, 250 mg, NDC 64980010401, Pedigree: AD70639_10, EXP: 5/29/2014.

Code information: MAGNESIUM CHLORIDE DR, Tablet, 64 mg has the following codes Pedigree: AD54510_1, EXP: 2/28/2014; Pedigree: AD70615_1, EXP: 2/28/2014.

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