FDA recall D-0042-2021

eVenus Pharmaceutical Laboratories · Class III · drug

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

Reason for recall

DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking.

Distribution

CO only

Key facts

Status: Terminated
Initiation date: 2020-10-06
Report date: 2020-10-28
Termination date: 2022-05-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0042-2021