Fresenius Kabi USA, LLC recalls Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, Rx Only, Mfd. by: Fresenius Kabi,
Recalled July 24, 2019 · FDA recall D-1489-2019 · Fresenius Kabi USA
Hazard
Presence of Particulate Matter; glass particulates · FDA Class I
Units
14,016 vials
Sold at
Nationwide USA and Puerto Rico
Description
Presence of Particulate Matter; glass particulates
Product
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]
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →