Fresenius Kabi USA, LLC is voluntarily recalling 2 lots of Fluorouracil Injection, USP 5g/100mL (50mg/mL), 100mL fill in 100mL vials, due to the potential for glass particulate.
The recalled products, distributed between December 6, 2018 and February 20, 2019, have the following NDC number, lot number, and expiration date:
- 63323-117-69, 6120341, 4/2020
- 63323-117-61, 6120420, 4/2020
The Company found glass particulate in 5 vials from a sample inventory of lot 6120341 during an inspection for a quality investigation. Additionally, lot 6120420 was included in the recall as a precautionary measure as it was produced in the same filling campaign. According to Fresenius Kabi, no reports of adverse events have been received at this time.
Fluorouracil, a nucleoside metabolic inhibitor, is indicated for the treatment of adenocarcinoma of the colon and rectum, adenocarcinoma of the breast, gastric adenocarcinoma, and pancreatic adenocarcinoma.
For more information visit fresenius-kabi.com.