Drug product
COLESTIPOL HCL MICRONIZED Tablet, 1 g, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762045001
D-643-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120 Tablets
- Official record key
drug-enforcement:D-643-2014
Official wording
Reason: Labeling:Label Mixup; COLESTIPOL HCL MICRONIZED Tablet, 1 g may be potentially mislabeled as rifAXIMin, Tablet, 200 mg, NDC 65649030103, Pedigree: AD54587_10, EXP: 4/30/2014.
Code information: COLESTIPOL HCL MICRONIZED, Tablet, 1 g has the following code Pedigree: AD56847_1, EXP: 5/21/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled