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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

Product Description Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only, Manufactured in the USA for Nexus Pharmaceuticals Inc, Lincolnshire, IL 60069, NDC 14789-300-02
Recall Number D-925-2013
Classification Class II
Code Info a) Lot: 112911, Exp. 11/13, b) Lot: 030712, Exp. 3/14
Product Distributed Qty 46,185 vials
Reason For Recall Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.

Event Detail

Event Id 65853
Product Type Drugs
Status Ongoing
Recalling Firm Nexus Pharmaceuticals Inc
City Vernon Hills
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-01
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide