FDA Drug recall D-1543-2014
CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distributed by Bedford Laboratories, Bedford, OH 44146, M…
- FDA Drug
- Class II
- terminated
- Published 2014-08-27
On 2014-08-27 the FDA classified a Class II recall of CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx only, Distributed by Bedford Laboratories, Bedford, OH 44146, M… by Ben Venue Laboratories, citing lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1543-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-31 |
| Published | 2014-08-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Ben Venue Laboratories |
| Distribution | US |
Product
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 55390-808-01
Reason
Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
Identifiers
| code_info | Lot # 0161-13-2167551; Exp. 07/14 Lot # 0161-13-2176919; Exp. 08/14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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FDA Drug · Class I · 2014-05-28 · Ben Venue Laboratories - Leucovorin Calcium Injection USP, single use vials, 10mg/mL
FDA Drug · Class II · 2012-11-07 · Ben Venue Laboratories - Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vials, lyophilized powder per carton, Rx Only, Mfr
FDA Drug · Class I · 2012-10-03 · Ben Venue Laboratories - Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 mL single use vials per pack, Rx only, Manufactured by: Ben Ven…
FDA Drug · Class II · 2012-06-20 · Ben Venue Laboratories - Octreotide Acetate Injection, 50 mcg/mL (0.05 mg/mL), 1 mL single dose vials, packaged in 10 x 1 mL single dose vials per pack, Rx only, Ma…
FDA Drug · Class II · 2012-06-20 · Ben Venue Laboratories
All Ben Venue Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1543-2014%22
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