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Recall Observatory FDA recall evidence

Drug product

guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000834

D-683-2014

July 02, 2013

Class II

Product summary

Firm
Aidapak Services, LLC
Event
Event 65707
Status
Terminated
Classification
Class II
Quantity
480 Tablets
Official record key
drug-enforcement:D-683-2014

Official wording

Reason: Labeling:Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: AD62829_18, EXP: 5/24/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: AD62834_4, EXP: 5/24/2014; diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: W003513, EXP: 6/21/2014; DOCUSATE SODIUM, Capsule, 250 mg,

Code information: guaiFENesin ER, Tablet, 600 mg has the following codes Pedigree: AD62834_4, EXP: 5/24/2014; Pedigree: AD62834_7, EXP: 5/24/2014; Pedigree: W003514, EXP: 6/21/2014; Pedigree: W003574, EXP: 6/24/2014; Pedigree: W003850, EXP: 6/27/2014; Pedigree: W003931, EXP: 6/28/2014; Pedigree: AD46429_1, EXP: 5/15/2014; Pedigree: AD73592_1, EXP: 5/31/2014.

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