Drug product
Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11
D-1514-2014
Product summary
- Event
- Event 66261
- Status
- Terminated
- Classification
- Class II
- Quantity
- 70,495 kits
- Official record key
drug-enforcement:D-1514-2014
Official wording
Reason: Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
Code information: Vial - 4212AAP1, Kit - 309316, Exp. 07/15
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample