FDA Drug Recalls

Recalls / Class II

Class IID-516-2014

Product

VENLAFAXINE Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714031101

Affected lot / code info
VENLAFAXINE Tablet, 25 mg has the following code Pedigree: AD67989_4, EXP: 11/30/2013.

Why it was recalled

Labeling: Label Mixup; VENLAFAXINE Tablet, 25 mg may be potentially mislabeled as OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, NDC 11523726503, Pedigree: AD65457_22, 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
100 Tablets
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-516-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.