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U.S. Department of Health and Human Services

Enforcement Report - Week of June 20, 2012

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Product Detail

Product Description 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 Venue Laboratories, Inc., Bedford, OH 44146; Manufactured for: Bedford Laboratories, Bedford, OH 44146, NDC 55390-138-01; UPC 3 55390-138-01 8.
Recall Number D-1376-2012
Classification Class II
Code Info Lot #1856177, Exp 06/30/13
Product Distributed Qty 11,161 packs
Reason For Recall Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.

Event Detail

Event Id 61802
Product Type Drugs
Status Ongoing
Recalling Firm Ben Venue Laboratories Inc
City Bedford
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-01
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico.