Why it was recalled
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
Product description
Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11
Lot numbers, UPCs & expiration codes
Vial - 4212AAP1, Kit - 309316, Exp. 07/15
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1514-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 11, 2013
- FDA report date
- Aug 13, 2014
- Quantity
- 70,495 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Janssen Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1514-2014, exactly as published.
Show all FDA fields
- City
- Titusville
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 66261
- Address
- 1125 Trenton Harbourton Rd
- Code information
- Vial - 4212AAP1, Kit - 309316, Exp. 07/15
- Postal code
- 08560-1503
- Report date
- Aug 13, 2014
- Product type
- Drugs
- Recall number
- D-1514-2014
- Classification
- Class II
- Recalling firm
- Janssen Pharmaceuticals, Inc.
- Product quantity
- 70,495 kits
- Termination date
- Jan 23, 2015
- Reason for recall
- Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 11, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Aug 5, 2014