FDA-Drug2014-12-17Class II
ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02
Fresenius Kabi USA, LLC
Hazard
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Sold states
U.S. Nationwide Including Puerto Rico
Affected count
184,550 Vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0296-2015Don't want to check this manually?
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