Risperdal CONSTA recall: Sterility Concern
Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11
Why was Risperdal CONSTA recalled?
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Vial - 4212AAP1, Kit - 309316, Exp. 07/15
- Product
- Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11
- Recalling firm
- Janssen Pharmaceuticals, Inc.
- Quantity
- 70,495 kits
- Distribution
- Nationwide
- Recall date
- August 13, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)