Recalls / Class II

Class IID-502-2014

Product

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

Affected lot / code info

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.

Why it was 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.

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

14301 Se 1st St, Vancouver, Washington 98684-3501

Distribution

Quantity

294 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-502-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.