Drug product
SOTALOL HCL, Tablet, 160 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093106201.
D-834-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 101 Tablets
- Official record key
drug-enforcement:D-834-2014
Official wording
Reason: Labeling: Label Mixup: SOTALOL HCL, Tablet, 160 mg may have potentially been mislabeled as the following drug: DISULFIRAM, Tablet, 250 mg, NDC 64980017101, Pedigree: AD22609_1, EXP: 5/2/2014.
Code information: SOTALOL HCL, Tablet, 160 mg has the following codes: Pedigree: AD22609_10, EXP: 4/30/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled