FDAFDA · Food and drugs·Recall number D-683-2014
guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000834
Published January 22, 2014 · Recall initiated: July 2, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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,
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Aidapak Services, LLC
- Distributor
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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