Medications & Supplements/Prescription Drugs

AbbVie Inc.: Ultane (sevoflurane) Inhalation Anesthetic Recalled for Defective Cap Liners

Agency Publication Date: February 9, 2018

Summary

AbbVie Inc. is recalling approximately 7,770 bottles of Ultane (sevoflurane) inhalation anesthetic (250 mL). The recall was initiated because of a manufacturing defect where holes were found in the liners of the bottle caps, creating a possibility for the medication to leak. This product is a prescription inhalation anesthetic used during surgery.

Risk

A hole in the bottle cap liner can lead to product leakage, which may result in reduced availability of the medication during a procedure or potential exposure to the anesthetic gas for healthcare providers.

What You Should Do

Check your inventory for Ultane (sevoflurane), 250 mL bottles with NDC 0074-4456-51.
Identify affected units by looking for Lot number 1088856 with an expiration date of June 2020 (6/20).
Contact your healthcare provider or pharmacist for guidance regarding this recall and to discuss alternative supplies if necessary.
Return any unused bottles from the affected lot to your pharmacy or place of purchase for a refund.
Contact the manufacturer, AbbVie Inc., at 1 N Waukegan Rd, North Chicago, IL 60064 for further instructions regarding the return process.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact healthcare provider and return product for refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Ultane (sevoflurane), 250 mL, Inhalation Anesthetic

Model:

NDC 0074-4456-51

Lot Numbers:

1088856 (Exp 6/20)

Date Ranges: Exp 6/20

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78969

Status: Resolved

Manufacturer: AbbVie Inc.

Sold By: pharmacies; hospitals

Manufactured In: United States

Units Affected: 7,770 bottles

Distributed To: Mississippi, Ohio

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your inventory for Ultane (sevoflurane), 250 mL bottles with NDC 0074-4456-51.

Identify affected units by looking for Lot number 1088856 with an expiration date of June 2020 (6/20).

Contact your healthcare provider or pharmacist for guidance regarding this recall and to discuss alternative supplies if necessary.

Return any unused bottles from the affected lot to your pharmacy or place of purchase for a refund.

Contact the manufacturer, AbbVie Inc., at 1 N Waukegan Rd, North Chicago, IL 60064 for further instructions regarding the return process.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.