PlainRecalls
FDA Drug Moderate Class II Terminated

OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503

Reported: January 22, 2014 Initiated: July 2, 2013 #D-502-2014

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.

Details

Recalling Firm
Aidapak Services, LLC
Units Affected
294 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/1,110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503. Recalled by Aidapak Services, LLC. Units affected: 294 Capsules.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 22, 2014. Severity: Moderate. Recall number: D-502-2014.