PlainRecalls
FDA Drug Moderate Class II Terminated

OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503

Reported: January 22, 2014 Initiated: July 2, 2013 #D-501-2014

Product Description

OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503

Reason for Recall

Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: W003788, EXP: 6/27/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003870, EXP: 6/27/2014.

Details

Recalling Firm
Aidapak Services, LLC
Units Affected
210 Capsules
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Location
Vancouver, WA

Frequently Asked Questions

What product was recalled?
OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503. Recalled by Aidapak Services, LLC. Units affected: 210 Capsules.
Why was this product recalled?
Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: W003788, EXP: 6/27/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W003870, EXP: 6/27/2014.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 22, 2014. Severity: Moderate. Recall number: D-501-2014.