drugs Class II Updated 2013-07-17

Fresenius Kabi USA, LLC recalls Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL),

Recalled Product

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

Hazard / Issue

Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: a) Lot: 111412, Exp: 11/2014 b) Lots: 030712, Exp: 03/2014; 071212, Exp: 07/2014; 090512, Exp: 09/2014;
View official government recall

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