October 2020 FDA Recall Desflurane by Evenus Pharmaceutical Laboratories
D-0042-2021 - DEFECTIVE CONTAINER
This Class III drug recall was voluntarily initiated by Evenus Pharmaceutical Laboratories on October 6, 2020 for the product Desflurane. The FDA reported the reason for recall as defective container. The product was distributed in CO only and the recall is currently terminated.
Recall Number: D-0042-2021
DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking.
10-06-2020
10-28-2020
9210 units
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
eVenus Pharmaceutical Laboratories
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.
CO only
05-19-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Desflurane, USP Liquid for Inhalation, 240 mL, Rx Only, Manufactured by: Shanghai Hengrui Pharmaceutical Co., Ltd., Shanghai, 200245, China for Sandoz Inc. Princeton, NJ 08540, NDC 0781-6172-22
Batch or Lot Expiration Information
Lot# : 20011831, Exp. Date 12/2021; 20041431, Exp. Date 03/2022
