Drug product
VENLAFAXINE Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714031101
D-516-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-516-2014
Official wording
Reason: 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.
Code information: VENLAFAXINE Tablet, 25 mg has the following code Pedigree: AD67989_4, EXP: 11/30/2013.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled