Drug recall
Invega Sustenna (paliperdione palmitate) extended-release injectable suspension, 234 mg, 1.5 mL prefilled…
FDA recall event 57938 · Class II · Ortho-McNeil Pharmaceutical, Inc.
Key facts
| Event ID | 57938 |
|---|---|
| Recall numbers | D-354-2011 |
| Recalling firm | Ortho-McNeil Pharmaceutical, Inc. |
| Product type | Drugs |
| Products | Invega Sustenna (paliperdione palmitate) extended-release injectable suspension, 234 mg, 1.5 mL prefilled syringe and 2 needles per kit, a) (trade) NDC 50458-564-01, b) (samples not for sale) NDC… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility: Invega Sustenna Extended-Release Injectable Suspection 234 mg strength is being recalled after a detection that some of the pre-filled syringes of the 234 mg strength… |
| Initiation date | Feb 11, 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