Drug product
OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503
D-503-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 84 Capsules
- Official record key
drug-enforcement:D-503-2014
Official wording
Reason: Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg may be potentially mislabeled as BENZOCAINE/MENTHOL, LOZENGE, 15 mg/2.6 mg, NDC 63824073116, Pedigree: AD42592_4, EXP: 5/14/2014.
Code information: OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg has the following code Pedigree: AD42584_15, EXP: 5/14/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled