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Recall Observatory FDA recall evidence

Drug product

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

D-0819-2016

April 05, 2016

Class II

Product summary

Firm
Fresenius Kabi USA, LLC
Event
Event 73751
Status
Terminated
Classification
Class II
Quantity
94,560 vials
Official record key
drug-enforcement:D-0819-2016

Official wording

Reason: 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.

Code information: Lot #: 6010157, Exp. 01/2017

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.