Drug recall D-1386-2019

Class III Terminated reported Jun 19, 2019

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

Reason for recall

Failed Impurities/Degradation Specifications.

Lots and codes

Lot #: 6018699, Exp. 12/2021

Recall details

Recalling firm
Fresenius Kabi USA, LLC, Grand Island, NY
Quantity
11,981 units
Distribution
Nationwide within the United States
Type
Voluntary: Firm initiated
Recall initiated
May 22, 2019
Terminated
January 28, 2021

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