Drug product
TERBUTALINE SULFATE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00115261101.
D-859-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 101 Tablets
- Official record key
drug-enforcement:D-859-2014
Official wording
Reason: Labeling: Label Mixup: TERBUTALINE SULFATE, Tablet, 2.5 mg may have potentially been mislabeled as the following drug: SOTALOL HCL, Tablet, 80 mg, NDC 00093106101, Pedigree: AD52778_85, EXP: 5/21/2014.
Code information: TERBUTALINE SULFATE, Tablet, 2.5 mg has the following codes: Pedigree: AD52778_88, EXP: 5/21/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled