June 2019 FDA Recall Sevoflurane by Baxter Healthcare Corporation
D-1435-2019 - Failed Stability Specifications
This Class II drug recall was voluntarily initiated by Baxter Healthcare Corporation on June 13, 2019 for the product Sevoflurane. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1435-2019
Failed Stability Specifications
06-13-2019
06-19-2019
5940 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Baxter Healthcare Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
04-29-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
