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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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.
- Category
- Drug — Inhalation Anesthetic
- Hazard
- 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
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