Drug recall
Risperdal Tablets (Risperidone), 3 mg, 60 count bottles, Rx only, Janssen Pharmaceutical Products, LP…
FDA recall event 59121 · Class II · Ortho-McNeil Pharmaceutical, Inc.
Key facts
| Event ID | 59121 |
|---|---|
| Recall numbers | D-709-2011, D-710-2011 |
| Recalling firm | Ortho-McNeil Pharmaceutical, Inc. |
| Product type | Drugs |
| Products | Risperdal Tablets (Risperidone), 3 mg, 60 count bottles, Rx only, Janssen Pharmaceutical Products, LP, Titusville, NJ ---NDC 50458-330-06, Risperidone Tablets 2 mg, 60 count bottles, Rx only, Mfd. by JOLLC, Gurabo, Puerto Rico 00778, Mfd for: Patriot Pharmaceuticals, LLC, Horsham, PA --- NDC 50458-593-60 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Chemical contamination; TBA, Chemical Contamination; TBA |
| Initiation date | Jun 16, 2011 |
| Termination date | Dec 20, 2012 |
| City | Raritan |
| State | NJ |
| Country | United States |
| FEI number | 2211100 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports