D-502-2014 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
- 294 Capsules
Product Description
OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503
Reason for Recall
Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg may be potentially mislabeled as ACETAMINOPHEN, CHEW Tablet, 80 mg, NDC 00536323307, Pedigree: AD49399_1, EXP: 5/16/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD46300_11, EXP: 5/15/2014; MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 00781206701, Pedigree: AD65457_7, EXP: 5/24/2014.
Distribution Pattern
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Code Information
OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg has the following codes Pedigree: AD49399_4, EXP: 5/16/2014; Pedigree: AD46300_17, EXP: 5/15/2014; Pedigree: AD65457_22, EXP: 5/24/2014.