FDA-Drug2019-06-19Class III

Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20

Fresenius Kabi USA, LLC
Hazard

Failed Impurities/Degradation Specifications.

Sold states
Nationwide within the United States
Affected count
11,981 units
Manufactured in
3159 Staley Rd, N/A, Grand Island, NY, United States
Products
Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1386-2019

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