April 2016 FDA Recall Cisatracurium by Fresenius Kabi Usa, Llc
D-0819-2016 - Incorrect/ Undeclared Excipient
This Class II drug recall was voluntarily initiated by Fresenius Kabi Usa, Llc on April 5, 2016 for the product Cisatracurium. The FDA reported the reason for recall as incorrect/ undeclared excipient. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0819-2016
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.
04-05-2016
04-20-2016
94,560 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Fresenius Kabi USA, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
04-11-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 6010157, Exp. 01/2017
