FDA-Drug2013-07-17Class II
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
Fresenius Kabi USA, LLC
Hazard
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials
Sold states
Nationwide & Puerto Rico
Affected count
65110 vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-685-2013Don't want to check this manually?
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