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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02
Recall Number D-1326-2014
Classification Class I
Code Info 2005479, Exp 03/14
Product Distributed Qty 5,131 vials
Reason For Recall Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution

Event Detail

Event Id 67512
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 2014-02-14
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide.