FDAFDA · Food and drugs·Recall number D-508-2014
lamoTRIgine, Tablet, 50 mg (1/2 of 100 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 13668004701
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; lamotrigine, Tablet, 50 mg (1/2 of 100 mg) may be potentially mislabeled as OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg), NDC 00603497521, Pedigree: AD73525_64, EXP: 5/30/2014; FEXOFENADINE HCL, Tablet, 60 mg, NDC 45802042578, Pedigree: AD46257_50, EXP: 5/15/2014.
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
- lamoTRIgine, Tablet, 50 mg (1/2 of 100 mg) has the following codes Pedigree: ADWA00002116, EXP: 5/31/2014; Pedigree: AD46265_31, EXP: 5/15/2014.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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