Drug product
SOTALOL HCL, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093106101.
D-833-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 202 Tablets
- Official record key
drug-enforcement:D-833-2014
Official wording
Reason: 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.
Code information: SOTALOL HCL, Tablet, 80 mg has the following codes: Pedigree: AD30993_17, EXP: 5/9/2014; Pedigree: AD52778_85, EXP: 5/21/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled