Ultane Liquid
FDA Recall NDC 0074-4456
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Ultane (NDC 0074-4456). A significant event, classified as Class III, was initiated on Jan 22, 2018 by Abbvie Inc.. The reported reason for this action was: "Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
Jan 22, 2018
Feb 07, 2018
7,770 bottles
Recall Profile & Regulatory Data
Event ID
78969
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
AbbVie Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
MS, OH
Termination Date
Sep 13, 2018
Product Description
Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51
Batch or Lot Expiration Information
Lot# : 1088856, Exp 6/20
Affected Packages Involved in this Recall
0074-4456-51Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
