Ben Venue Laboratories recalls
Ben Venue Laboratories appears in 6 official U.S. recall notices indexed by RecallRadar, most recently on 2014-08-27.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 6 |
|---|---|
| Published | 2012-06-20 to 2014-08-27 |
| By agency | FDA Drug (6) |
| By classification | Class II (4), Class I (2) |
| By status | terminated (6) |
| Distribution named in notices | US |
Recalls
- 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 · 2014-08-27 · Ben Venue Laboratories
Reason: Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity. - Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02
FDA Drug · Class I · 2014-05-28 · Ben Venue Laboratories
Reason: Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution - Leucovorin Calcium Injection USP, single use vials, 10mg/mL
FDA Drug · Class II · 2012-11-07 · Ben Venue Laboratories
Reason: Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample. - 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
Reason: Presence of Particulate Matter - 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
Reason: Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution. - 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
Reason: Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.