Ben Venue Laboratories Inc
FDA Regulatory Profile
Ben Venue Laboratories Inc appears in FDA public data with 6 recalls — including 2 Class I (most serious) —, 1 510(k) clearance, 10 FDA inspections, and 1 compliance action on record. Its most recent recall (D-1543-2014, Class II) was initiated on July 31, 2014. Its most recent 510(k) clearance was granted on December 29, 1983.
Summary
- Total Recalls
- 6 (2 Class I)
- 510(k) Clearances
- 1
- Inspections
- 10
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-1543-2014 | Class II | CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distributed by Bed | July 31, 2014 |
| D-1326-2014 | Class I | Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, N | February 14, 2014 |
| D-036-2013 | Class II | Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manufactured by: Ben Ven | July 5, 2012 |
| D-1697-2012 | Class I | Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vials, lyophilized pow | June 26, 2012 |
| D-1377-2012 | Class II | Octreotide Acetate Injection, 50 mcg/mL (0.05 mg/mL), 1 mL single dose vials, packaged in 10 x 1 mL | May 1, 2012 |
| D-1376-2012 | Class II | Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 mL single use vials per | May 1, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K833457 | ETHYLENE OXIDE GAS STERILIZA SYS II | December 29, 1983 |