D-503-2014 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 22, 2014
- Initiation Date
- July 2, 2013
- Termination Date
- February 7, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 84 Capsules
Product Description
OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503
Reason for Recall
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.
Distribution Pattern
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Code Information
OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg has the following code Pedigree: AD42584_15, EXP: 5/14/2014.