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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 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.
Recall Number D-1377-2012
Classification Class II
Code Info Lot # 2006500, Exp 08/31/12
Product Distributed Qty 6,515 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.