Drug product
HYOSCYAMINE SULFATE ER, Tablet, 0.375 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43199001401
D-559-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 99 Tablets
- Official record key
drug-enforcement:D-559-2014
Official wording
Reason: Labeling: Label Mixup; HYOSCYAMINE SULFATE ER Tablet, 0.375 mg may be potentially mislabeled as SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: W003575, EXP: 6/24/2014.
Code information: HYOSCYAMINE SULFATE ER Tablet, 0.375 mg has the following code Pedigree: W003576, EXP: 6/24/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled