Desflurane Liquid
FDA Recall NDC 0781-6172
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Desflurane (NDC 0781-6172). A significant event, classified as Class III, was initiated on Oct 06, 2020 by Sandoz Inc.. The reported reason for this action was: "DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking.
Oct 06, 2020
Oct 28, 2020
9210 units
Recall Profile & Regulatory Data
Event ID
86568
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
eVenus Pharmaceutical Laboratories
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
CO only
Termination Date
May 19, 2022
Product Description
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
Affected Packages Involved in this Recall
0781-6172-22Product
0781-6172-86Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
