CLASS III Drug recall · Reported 7 Feb 2018 · FDA Enforcement Report
Ultane (sevoflurane), Inhalation Anesthetic recalled by AbbVie
AbbVie is recalling Ultane (sevoflurane), Inhalation Anesthetic, distributed in Mississippi, Ohio. The recall was initiated on 22 Jan 2018 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0412-2018
- FDA event ID
- 78969
- Recalling firm
- AbbVie, North Chicago, IL
- Brand
- Ultane
- Manufacturer
- AbbVie Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Jan 2018
- FDA classified
- 9 Feb 2018
- Reported
- 7 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 22 Jan 2018 | Recall initiated by company | |
| 7 Feb 2018 | Published in enforcement report | +16 days |
| 9 Feb 2018 | Classified by FDA | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51
Where it was distributed
MS, OH
Questions about this recall
Why was it recalled?
Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
Which lots are affected?
Lot #: 1088856, Exp 6/20
Where was it sold?
MS, OH
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Sevoflurane recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sevoflurane, USP Inhalation Anesthetic recalled by Baxter HealthcareSevoflurane | Baxter Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Sevoflurane, USP (Inhalation Anesthetic) recalledSevoflurane | Piramal Critical Care | Other | Nationwide |