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Recall Observatory FDA recall evidence

Drug product

ISOSORBIDE MONONITRATE ER Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175012837

D-671-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
700 Tablets
Official record key
drug-enforcement:D-671-2014

Official wording

Reason: Labeling:Label Mixup; ISOSORBIDE MONONITRATE ER Tablet, 30 mg may be potentially mislabeled as LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: W003899, EXP: 6/27/2014; MISOPROSTOL, Tablet, 100 mcg, NDC 43386016012, Pedigree: AD42611_7, EXP: 5/14/2014; hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W003332, EXP: 6/18/2014; glyBURIDE, Tablet, 2.5 mg, NDC 0009383

Code information: ISOSORBIDE MONONITRATE ER Tablet, 30 mg has the following codes Pedigree: W003996, EXP: 7/1/2014; Pedigree: AD46297_1, EXP: 5/15/2014; Pedigree: W003350, EXP: 6/18/2014; Pedigree: AD21790_64, EXP: 5/1/2014; Pedigree: AD32757_37, EXP: 5/14/2014.

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