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Recall Observatory FDA recall evidence

Drug product

LANTHANUM CARBONATE Chew Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 54092025290

D-615-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
405 Chew Tablets
Official record key
drug-enforcement:D-615-2014

Official wording

Reason: Labeling: Label Mixup; LANTHANUM CARBONATE Chew Tablet, 500 mg may be potentially mislabeled as ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: AD32757_31, EXP: 5/13/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: AD32757_53, EXP: 5/14/2014; MAGNESIUM CHLORIDE, Tablet, 64 mg, NDC 68585000575, Pedigree: W002712, EXP: 6/6/2014; MAGNESIUM CHLORIDE, Tablet, 64 mg, NDC 68

Code information: LANTHANUM CARBONATE, Chew Tablet, 500 mg has the following codes Pedigree: AD32764_5, EXP: 5/13/2014; Pedigree: AD32764_8, EXP: 5/14/2014; Pedigree: W002790, EXP: 6/6/2014; Pedigree: W003410, EXP: 6/19/2014.

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