Recalls / Class II
Class IID-1514-2014
Product
Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11
- Brand name
- Risperdal Consta
- Generic name
- Risperidone
- NDCs
- 50458-306, 50458-309, 50458-307, 50458-308
- FDA application
- NDA021346
- Affected lot / code info
- Vial - 4212AAP1, Kit - 309316, Exp. 07/15
Why it was recalled
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
Recalling firm
- Firm
- Janssen Pharmaceuticals, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1125 Trenton Harbourton Rd, N/A, Titusville, New Jersey 08560-1503
Distribution
- Quantity
- 70,495 kits
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-09-11
- FDA classified
- 2014-08-05
- Posted by FDA
- 2014-08-13
- Terminated
- 2015-01-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1514-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.