Class II
Terminated
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
- Company
- Fresenius Kabi Usa, Llc
- Recall Initiated
- July 1, 2013
- Posted
- July 17, 2013
- Recall Number
- D-685-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 65110 vials
- Firm Location
- Lake Zurich, IL, United States
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
Distribution
Nationwide & Puerto Rico
Lot / Code Info
a) Lot: 111412, Exp: 11/2014 b) Lots: 030712, Exp: 03/2014; 071212, Exp: 07/2014; 090512, Exp: 09/2014;
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