FDA-Drug2019-07-24Class I
Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand]
Fresenius Kabi USA, LLC
Hazard
Presence of Particulate Matter; glass particulates
Sold states
Nationwide USA and Puerto Rico
Affected count
14,016 vials
Manufactured in
2045 Cornell Ave, N/A, Melrose Park, IL, United States
Products
Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi, Lake Zurich, IL 60047. 63323-117-61 [Fresenius Kabi brand] and NDC 63323-117-69 [NOVAPLUS brand]
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1489-2019Don't want to check this manually?
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