Drug product
MESALAMINE CR Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 54092018981
D-613-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 240 Capsules
- Official record key
drug-enforcement:D-613-2014
Official wording
Reason: Labeling: Label Mixup; MESALAMINE CR, Capsule, 250 mg may be potentially mislabeled as ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: AD52378_1, EXP: 5/17/2014.
Code information: MESALAMINE CR, Capsule, 250 mg has the following code Pedigree: AD52412_1, EXP: 5/17/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled