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