FDA Recalls Desflurane Liquid for Inhalation Due to Container Leaks
eVenus Pharmaceutical Laboratories is recalling Desflurane Liquid for Inhalation because the containers may be leaking. The recall affects 9,210 units distributed in Colorado.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classifies this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The defect is a packaging issue (leaking container) without reported injuries.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Desflurane Liquid for Inhalation, 240 mL, manufactured by eVenus Pharmaceutical Laboratories. The recall is due to a defect where the product containers may be leaking. The affected product is a prescription-only general anesthetic used for inhalation.
The recall involves 9,210 units of the medication. The specific lots affected are 20011831 (expiration date 12/2021) and 20041431 (expiration date 03/2022). The product was distributed only in the state of Colorado (CO). The medication is manufactured by Shanghai Hengrui Pharmaceutical Co., Ltd. for Sandoz Inc.
Healthcare providers and patients who have this product should stop using it and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication. This recall is classified as Class III by the FDA, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- DESFLURANE (DESFLURANE)
- Brand
- DESFLURANE
- Manufacturer
- eVenus Pharmaceutical Laboratories
- Category
- Drug — General Anesthetic
- Affected units
- 9,210
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 20011831
- Exp. Date 12/2021
- 20041431
- Exp. Date 03/2022
UPCs (1)
- 0307816172229
Distribution
Distributed in 1 state:
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