Drug product
VENLAFAXINE HCL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093738301.
D-847-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 Tablets
- Official record key
drug-enforcement:D-847-2014
Official wording
Reason: Labeling: Label Mixup: VENLAFAXINE HCL, Tablet, 100 mg may have potentially was mislabeled as tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: AD73525_31, EXP: 5/30/2014; and may have potentially been mislabeled as one of the following drugs: methylPREDNISolone, Tablet, 4 mg, NDC 00603459321, Pedigree: AD32764_11, EXP: 3/31/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree:
Code information: VENLAFAXINE HCL, Tablet, 100 mg has the following codes: Pedigree: AD73525_37, EXP: 5/30/2014; Pedigree: AD42566_1, EXP: 5/14/2014; Pedigree: W002619, EXP: 6/4/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled