Drug product
SENNOSIDES Tablet, 8.6 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258095001
D-656-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 Tablets
- Official record key
drug-enforcement:D-656-2014
Official wording
Reason: Labeling:Label Mixup; SENNOSIDES Tablet, 8.6 mg may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: AD37063_7, EXP: 5/13/2014.
Code information: SENNOSIDES, Tablet, 8.6 mg has the following code Pedigree: AD37063_17, EXP: 5/13/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled