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,…

Recall date

June 28, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1489-2019

FDA classification

Class I

Brand / firm

Fresenius Kabi USA, LLC

Sold / distributed

Nationwide USA and Puerto Rico

Why it was recalled

Presence of Particulate Matter; glass particulates

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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]