FDAFDA · Food and drugs·Recall number D-833-2014
SOTALOL HCL, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093106101.
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: SOTALOL HCL, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: DILTIAZEM HCL, Tablet, 120 mg, NDC 00093032101, Pedigree: AD30197_1, EXP: 5/9/2014; PROPRANOLOL HCL ER, Capsule, 60 mg, NDC 00228277811, Pedigree: AD54605_4, EXP: 5/20/2014.
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
- SOTALOL HCL, Tablet, 80 mg has the following codes: Pedigree: AD30993_17, EXP: 5/9/2014; Pedigree: AD52778_85, EXP: 5/21/2014.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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