Drug product
Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by: Teva Pharmaceuticals USA, 1090 Horsham Rd, North Wales, PA 19454, NDC 63739-0512-10
D-1167-2014
Product summary
- Event
- Event 67747
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,557 Boxes
- Official record key
drug-enforcement:D-1167-2014
Official wording
Reason: Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.
Code information: Lot #: 91357
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of Specification