FDA recall D-0412-2018

AbbVie Inc. · Class III · drug

Product

Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51

Reason for recall

Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.

Distribution

MS, OH

Key facts

Status
Terminated
Initiation date
2018-01-22
Report date
2018-02-07
Termination date
2018-09-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
North Chicago, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0412-2018