May 2019 FDA Recall Ondansetron by Fresenius Kabi Usa, Llc
D-1386-2019 - Failed Impurities/Degradation Specifications.
This Class III drug recall was voluntarily initiated by Fresenius Kabi Usa, Llc on May 22, 2019 for the product Ondansetron. The FDA reported the reason for recall as failed impurities/degradation specifications.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1386-2019
Failed Impurities/Degradation Specifications.
05-22-2019
06-19-2019
11,981 units
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Fresenius Kabi USA, LLC
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
01-28-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20
Batch or Lot Expiration Information
Lot# : 6018699, Exp. 12/2021
