The Recall Desk
LowFDA (Drugs)·D-0412-2018·Announced 2018-02-07

AbbVie Recalls Ultane Sevoflurane Due to Defective Container Caps

AbbVie Inc. is recalling 7,770 bottles of Ultane (sevoflurane) inhalation anesthetic due to defective container caps that may leak.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the hazard is a packaging defect (leakage) rather than a direct toxicological or physical injury risk.

Plain-English summary

AbbVie Inc. is recalling 7,770 bottles of Ultane (sevoflurane), a prescription inhalation anesthetic. The recall is due to a defective container where holes in the liners of the caps covering the product bottle introduce the possibility of leakage.

The affected product is identified by Lot # 1088856 with an expiration date of 6/20. The NDC is 0074-4456-51. The distribution pattern for this recall is listed as MS and OH.

Consumers and healthcare providers should stop using the affected product and contact AbbVie Inc. for further instructions or a replacement.

The recalled product

Product
ULTANE (SEVOFLURANE)
Brand
ULTANE
Manufacturer
AbbVie Inc.
Affected units
7,770

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 1088856
  • Exp 6/20

Distribution

Distributed in 2 states: