Class III · Low risk
Ultane (sevoflurane)
Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
Sevoflurane
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Stability Specifications
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 10019-651-64
Affected NDC
10019-0651-64
Compare with the code on your package — it is the most precise check available.
Drug: Sevoflurane
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Sevoflurane NDC 10019-0651 |
250 mL/250mL | Liquid Respiratory (inhalation) |
Baxter Healthcare Company | Rx |
- Recalling firm
- Baxter Healthcare Corporation
- NDC code
- 10019-651-64
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1435-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Sevoflurane recalls
See all
Class II · Moderate risk
Sevoflurane
Failed pH Specifications: product was too acidic.
Other recalls by Baxter Healthcare Corporation
All 2019 recalls
Class I · High risk
Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
Class I · High risk
0.9% Sodium Chloride Injection USP 500 mL
Presence of particulate matter: Particulates identified as fiberglass
Class II · Moderate risk
Daptomycin
CGMP Deviations
Class II · Moderate risk
Vancomycin Injection
CGMP Deviations
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