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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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Product Detail

Product Description Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial, Rx only, labeled as a) Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-970-02; and b) Manufactured in the USA for Nexus Pharmaceuticals Inc., Vernon Hills, IL 60061, NDC 14789-300-02
Recall Number D-685-2013
Classification Class II
Code Info a) Lot: 111412, Exp: 11/2014 b) Lots: 030712, Exp: 03/2014; 071212, Exp: 07/2014; 090512, Exp: 09/2014;
Product Distributed Qty 65110 vials
Reason For Recall Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials

Event Detail

Event Id 65588
Product Type Drugs
Status Ongoing
Recalling Firm Fresenius Kabi USA, LLC
City Lake Zurich
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-01
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide & Puerto Rico