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Class II: temporary or reversible health riskTerminated

Baxter Healthcare Sevoflurane Recall

Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter…

Baxter Healthcare Corporation · Deerfield, IL

Risk level
Class II
Reported by FDA
Jun 19, 2019
Recall ID
D-1435-2019
Check your lot numberHow we source this data

Summary

Baxter Healthcare recalled Sevoflurane starting Jun 13, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1435-2019 on Jun 19, 2019. Reason: Failed Stability Specifications. Status: Terminated.

Why it was recalled

Failed Stability Specifications

Product description

Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 10019-651-64

Lot numbers, UPCs & expiration codes

Lot #: S110F822 Exp. 5/31/2021

Where it was sold

Nationwide within the United States

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1435-2019
Classification
Class II
Status
Terminated
Recall initiated
Jun 13, 2019
FDA report date
Jun 19, 2019
Quantity
5940 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Baxter Healthcare Corporation

Original FDA data

Every field from FDA enforcement report D-1435-2019, exactly as published.

Show all FDA fields
City
Deerfield
State
IL
Status
Terminated
Country
United States
Event ID
83055
Address
1 Baxter Pkwy
Code information
Lot #: S110F822 Exp. 5/31/2021
Postal code
60015-4625
Report date
Jun 19, 2019
Product type
Drugs
Recall number
D-1435-2019
Classification
Class II
Recalling firm
Baxter Healthcare Corporation
Product quantity
5940 bottles
Termination date
Apr 29, 2020
Reason for recall
Failed Stability Specifications
Voluntary / mandated
Voluntary: Firm initiated
Product description
Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 10019-651-64
Distribution pattern
Nationwide within the United States
Recall initiation date
Jun 13, 2019
Initial firm notification
Letter
Center classification date
Jun 28, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1435-2019, published Jun 19, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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