Drug product
MESALAMINE CR Capsule, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 54092019112
D-614-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 111 Capsules
- Official record key
drug-enforcement:D-614-2014
Official wording
Reason: Labeling: Label Mixup; MESALAMINE CR, Capsule, 500 mg may be potentially mislabeled as clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: AD21790_7, EXP: 5/1/2014.
Code information: MESALAMINE CR, Capsule, 500 mg has the following code Pedigree: AD21965_16, EXP: 5/1/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled