Sevoflurane Liquid
FDA Recall NDC 10019-655
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sevoflurane (NDC 10019-655). A significant event, classified as Class II, was initiated on Jun 13, 2019 by Baxter Healthcare Company. The reported reason for this action was: "Failed Stability Specifications"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Stability Specifications
Jun 13, 2019
Jun 19, 2019
5940 bottles
Recall Profile & Regulatory Data
Event ID
83055
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Apr 29, 2020
Product Description
Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 10019-651-64
Batch or Lot Expiration Information
Lot# : S110F822 Exp. 5/31/2021
Affected Packages Involved in this Recall
10019-651-64Product
10019-655-06Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
