Drug recall
CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distributed by Bedford…
FDA recall event 68800 · Class II · Ben Venue Laboratories Inc
Key facts
| Event ID | 68800 |
|---|---|
| Recall numbers | D-1543-2014 |
| Recalling firm | Ben Venue Laboratories Inc |
| Product type | Drugs |
| Products | CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distributed by Bedford Laboratories, Bedford, OH 44146, Manufactured by Ben Venue Labs, Inc., Bedford, OH 44146, NDC… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity. |
| Initiation date | Jul 31, 2014 |
| Report date | Aug 27, 2014 |
| Termination date | Dec 2, 2014 |
| 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 · Source date: