FDA-Drug2016-04-20Class II
Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-417-10
Fresenius Kabi USA, LLC
Hazard
Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.
Sold states
Nationwide and Puerto Rico
Affected count
94,560 vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-417-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0819-2016Don't want to check this manually?
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