Drug recall
Fluphenazine Decanoate Injection, USP 25 mg/mL, 5 mL multiple dose vial, For IM or SC Use, Rx Only…
FDA recall event 50218 · Class II · Ben Venue Laboratories Inc
Key facts
| Event ID | 50218 |
|---|---|
| Recall numbers | D-165-2009 |
| Recalling firm | Ben Venue Laboratories Inc |
| Product type | Drugs |
| Products | Fluphenazine Decanoate Injection, USP 25 mg/mL, 5 mL multiple dose vial, For IM or SC Use, Rx Only, Manufactured by Ben Venue Laboratories, Inc. Bedford, OH 44146, Manufactured for Bedford… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Exceeds Impurity Specification (6 month stability) |
| Initiation date | Nov 21, 2008 |
| Termination date | Oct 13, 2010 |
| City | Bedford |
| State | OH |
| Country | United States |
| FEI number | 1519257 |
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