Drug product
rifAXIMin Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65649030103
D-715-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 Tablets
- Official record key
drug-enforcement:D-715-2014
Official wording
Reason: Labeling:Label Mixup; rifAXIMin Tablet, 200 mg may be potentially mislabeled as CapsuleTOPRIL, Tablet, 25 mg, NDC 00143117201, Pedigree: AD52778_19, EXP: 5/20/2014.
Code information: rifAXIMin Tablet, 200 mg has the following code Pedigree: AD54587_10, EXP: 4/30/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled