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U.S. Department of Health and Human Services

Enforcement Report - Week of June 20, 2012
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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot #1856177, Exp 06/30/13 Class II Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution. 11,161 packs D-1376-2012
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, Manufactured for: Bedford Laboratories, Bedford, OH 44146; Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; NDC 55390-160-10; UPC 3 55390-160-10 1. Lot # 2006500, Exp 08/31/12 Class II Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution. 6,515 packs D-1377-2012
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