Recalls / Class III
Class IIID-0412-2018
Product
Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51
- Brand name
- Ultane
- Generic name
- Sevoflurane
- Active ingredient
- Sevoflurane
- Route
- Respiratory (inhalation)
- NDC
- 0074-4456
- FDA application
- NDA020478
- Affected lot / code info
- Lot #: 1088856, Exp 6/20
Why it was recalled
Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
Recalling firm
- Firm
- AbbVie Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 N Waukegan Rd, North Chicago, Illinois 60064-1802
Distribution
- Quantity
- 7,770 bottles
- Distribution pattern
- MS, OH
Timeline
- Recall initiated
- 2018-01-22
- FDA classified
- 2018-02-09
- Posted by FDA
- 2018-02-07
- Terminated
- 2018-09-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0412-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.