Recalls / Class II
Class IID-504-2014
Product
OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503
- Affected lot / code info
- 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.
Why it was recalled
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.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 210 Capsules
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-16
- Posted by FDA
- 2014-01-22
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-504-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.