FDAFDA · Food and drugs·Recall number D-1001-2014
ISOSORBIDE DINITRATE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781163501.
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: ISOSORBIDE DINITRATE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: CILOSTAZOL, Tablet, 100 mg, NDC 00054004421, Pedigree: W003470, EXP: 6/20/2014; PERPHENAZINE, Tablet, 8 mg, NDC 00630506221, Pedigree: AD54605_1, EXP: 4/30/2014.
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
- ISOSORBIDE DINITRATE, Tablet, 5 mg has the following codes: Pedigree: W003474, EXP: 6/20/2014; Pedigree: AD56882_1, EXP: 5/21/2014.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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