January 2018 FDA Recall Ultane by Abbvie Inc.
D-0412-2018 - Defective container

This Class III drug recall was voluntarily initiated by Abbvie Inc. on January 22, 2018 for the product Ultane. The FDA reported the reason for recall as defective container. The product was distributed in MS, OH and the recall is currently terminated.

Recall Number: D-0412-2018

Reason for Recall
Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
Initiated
01-22-2018
Reported
02-07-2018
Quantity
7,770 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78969
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AbbVie Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
MS, OH
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-13-2018
Product Description About Product Description
Full technical description of the product.
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

0074-4456-51 Ultane