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D-1697-2012 Class I Terminated

Recalled by Ben Venue Laboratories Inc — Bedford, OH

FDA drug recall D-1697-2012 was initiated by Ben Venue Laboratories Inc on June 26, 2012 and is designated Class I. Reason for recall: Presence of Particulate Matter The recall status is terminated (terminated February 3, 2014). Affected quantity: 797 boxes/10/20 mg vials.

Recall Details

Product Type: Drugs
Report Date: October 3, 2012
Initiation Date: June 26, 2012
Termination Date: February 3, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 797 boxes/10/20 mg vials

Product Description

Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vials, lyophilized powder per carton, Rx Only, Mfr. By: Ben Venue Laboratories, Bedford, OH 44146: Mfg for: Bedford Labs, Bedford, OH 44146, NDC 55390-039-10.

Reason for Recall

Presence of Particulate Matter

Distribution Pattern

Nationwide

Code Information

Lot #2067134 Exp 5/31/2013, NDC 55390-039-10

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D-036-2013 Class II — Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manu (July 5, 2012)
D-1377-2012 Class II — Octreotide Acetate Injection, 50 mcg/mL (0.05 mg/mL), 1 mL single dose vials, pa (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 s (May 1, 2012)