Recalls / Class II

Class IID-501-2014

Product

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

Affected lot / code info

OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg has the following codes Pedigree: W003789, EXP: 6/27/2014; Pedigree: W003873, EXP: 6/27/2014.

Why it was 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.

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-501-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.