Class II · Moderate risk Terminated
Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL…
Reason Failed Stability Specifications
Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
What was recalled
Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51
- Recalling firm
- AbbVie Inc.
- NDC code
- 0074-4456-51
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0412-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Sevoflurane recalls
See all
Class II · Moderate risk Terminated
Sevoflurane, USP (Inhalation Anesthetic), Rx Only, 250 mL Amber Bottle. Manufactured By: Piramal Critical Care, 3950 Schelden…
Reason Failed pH Specifications: product was too acidic.
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