Drug product
SOTALOL HCL, Tablet, 120 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093106001.
D-832-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 101 Tablets
- Official record key
drug-enforcement:D-832-2014
Official wording
Reason: Labeling: Label Mixup: SOTALOL HCL, Tablet, 120 mg may have potentially been mislabeled as the following drug: NEOMYCIN SULFATE, Tablet, 500 mg, NDC 51991073801, Pedigree: AD49448_17, EXP: 5/17/2014.
Code information: SOTALOL HCL, Tablet, 120 mg has the following codes: Pedigree: AD49448_20 EXP: 5/17/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled