Class II · Moderate risk
Sevoflurane
Failed Stability Specifications
Ultane (sevoflurane)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51
Affected NDC
0074-4456-51
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 |
|---|---|---|---|---|
| Ultane Sevoflurane NDC 00074-4456 |
250 mL/250mL | Liquid Respiratory (inhalation) |
AbbVie Inc. | Rx |
- Recalling firm
- AbbVie Inc.
- NDC code
- 0074-4456-51
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0412-2018 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 AbbVie Inc.
All 2018 recalls
Class III · Low risk
Pred Mild
Failed Stability Specifications
Class II · Moderate risk
Refresh LACRI-LUBE
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Class II · Moderate risk
Refresh P.M.
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Class III · Low risk
Synthroid
Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.
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