Drug product
HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574024701.
D-958-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 101 Tablets
- Official record key
drug-enforcement:D-958-2014
Official wording
Reason: Labeling: Label Mixup: HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg may have potentially been mislabeled as the following drug: FLUoxetine HCl, Capsule, 10 mg, NDC 16714035103, Pedigree: W003613, EXP: 6/25/2014.
Code information: HYOSCYAMINE SULFATE ODT, Tablet, 0.125 mg has the following codes: Pedigree: W003614, EXP: 6/25/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled