Cisatracurium Besylate Injection recalled over undeclared excipient

Recall date

April 5, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Fresenius Kabi USA, LLC recalls Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, R…

Recall number

D-0819-2016

FDA classification

Class II

Brand / firm

Fresenius Kabi USA, LLC

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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