Recalls / Class III
Class IIID-0042-2021
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
- Brand name
- Desflurane
- Generic name
- Desflurane
- Active ingredient
- Desflurane
- Route
- Respiratory (inhalation)
- NDC
- 0781-6172
- FDA application
- ANDA208234
- Affected lot / code info
- Lot #: 20011831, Exp. Date 12/2021; 20041431, Exp. Date 03/2022
Why it was recalled
DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking.
Recalling firm
- Firm
- eVenus Pharmaceutical Laboratories
- Manufacturer
- Sandoz Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 506 Carnegie Ctr, Suite 100, Princeton, New Jersey 08540-6243
Distribution
- Quantity
- 9210 units
- Distribution pattern
- CO only
Timeline
- Recall initiated
- 2020-10-06
- FDA classified
- 2020-10-20
- Posted by FDA
- 2020-10-28
- Terminated
- 2022-05-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0042-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.