FDA recall D-1489-2019

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]

Reason for recall

Presence of Particulate Matter; glass particulates

Distribution

Nationwide USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2019-06-28

Report date

2019-07-24

Termination date

2022-09-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Melrose Park, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1489-2019