RecallDepth
Class II Terminated

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

Company
Fresenius Kabi Usa, Llc
Recall Initiated
April 5, 2016
Posted
April 20, 2016
Recall Number
D-0819-2016
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
94,560 vials
Firm Location
Lake Zurich, IL, United States

Reason for Recall

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.

Distribution

Nationwide and Puerto Rico

Lot / Code Info

Lot #: 6010157, Exp. 01/2017

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