Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11
Reported: August 13, 2014 Initiated: September 11, 2013 #D-1514-2014
Product Description
Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11
Reason for Recall
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
Details
- Recalling Firm
- Janssen Pharmaceuticals, Inc.
- Units Affected
- 70,495 kits
- Distribution
- Nationwide
- Location
- Titusville, NJ
Frequently Asked Questions
What product was recalled? ▼
Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11. Recalled by Janssen Pharmaceuticals, Inc.. Units affected: 70,495 kits.
Why was this product recalled? ▼
Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 13, 2014. Severity: Moderate. Recall number: D-1514-2014.
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