Drug product
Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32) and b) 90-count bottle (NDC: 0131-3268-46), Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. For: Osmotica Pharmaceutical Corp., Wilmington, NC 28405, USA.
D-1067-2013
Product summary
- Event
- Event 66226
- Status
- Terminated
- Classification
- Class III
- Quantity
- 57857 bottles
- Official record key
drug-enforcement:D-1067-2013
Official wording
Reason: Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
Code information: Lot #: a) 58975, 58976, 58977, 65165 , Exp 01/14; b) 58973, 58974, 65131, Exp: 01/14
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specification