Drug product
Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (NDC 63629-3324-6), Rx Only, Manufactured by Teva Pharmaceuticals USA, Inc. Packaged by Bryant Ranch.
D-0837-2016
Product summary
- Event
- Event 73683
- Status
- Terminated
- Classification
- Class III
- Quantity
- 21 bottles (910 extended release tablets)
- Official record key
drug-enforcement:D-0837-2016
Official wording
Reason: Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.
Code information: Lot # 94983; Exp 10/17
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-Up