Recalls / Class II
Class IID-1435-2019
Product
Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 10019-651-64
- Brand name
- Sevoflurane
- Generic name
- Sevoflurane
- Active ingredient
- Sevoflurane
- Route
- Respiratory (inhalation)
- NDCs
- 10019-651, 10019-655
- FDA application
- ANDA075895
- Affected lot / code info
- Lot #: S110F822 Exp. 5/31/2021
Why it was recalled
Failed Stability Specifications
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Manufacturer
- Baxter Healthcare Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 5940 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-06-13
- FDA classified
- 2019-06-28
- Posted by FDA
- 2019-06-19
- Terminated
- 2020-04-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1435-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.