FDAFDA · Food and drugs·Recall number D-988-2014
OXYBUTYNIN CHLORIDE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603497521.
Published January 29, 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: OXYBUTYNIN CHLORIDE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: FLECAINIDE ACETATE, Tablet, 100 mg, NDC 00054001125, Pedigree: AD56847_4, EXP: 5/21/2014; SODIUM CHLORIDE, Tablet, 1 gm, NDC 00223176001, Pedigree: W003792, EXP: 6/27/2014; VARENICLINE, Tablet, 0.5 mg, NDC 00069046856, Pedigree: AD22616_1, EXP: 5/2/2014.
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
- OXYBUTYNIN CHLORIDE, Tablet, 5 mg has the following codes: Pedigree: AD52778_61, EXP: 5/20/2014; Pedigree: W003898, EXP: 6/27/2014; Pedigree: AD22616_4, EXP: 5/2/2014.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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