Drug product
OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503
D-504-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 210 Capsules
- Official record key
drug-enforcement:D-504-2014
Official wording
Reason: Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD70655_8, EXP: 5/29/2014; PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: AD73627_32, EXP: 5/30/2014.
Code information: OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg has the following codes Pedigree: AD70655_20, EXP: 5/29/2014; Pedigree: AD73627_35, EXP: 5/30/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled