Drug product
MESALAMINE DR, Capsule, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00430075327.
D-912-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 180 Capsules
- Official record key
drug-enforcement:D-912-2014
Official wording
Reason: Labeling: Label Mixup: MESALAMINE DR, Capsule, 400 mg may have potentially been mislabeled as the following drug: CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg, NDC 11868000901, Pedigree: AD34928_1, EXP: 5/9/2014.
Code information: MESALAMINE DR, Capsule, 400 mg has the following codes: Pedigree: AD34934_1, EXP: 1/31/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled