Fresenius Kabi Recalls Fluorouracil Injections

Drug Manufacturer Fresenius Kabi Voluntarily Recalls Fluorouracil Injections Which May Have the Presence of Glass Particulate

UNITED STATES – As reported online by www.fda.gov, Fresenius Kabi USA, LLC has issued a voluntary recall of two lots of Fluorouracil Injections which may have contained glass particulate.

Fresenius Kabi USA, LLC manufactures the chemotherapy drug Fluorouracil, which is administered intravenously.  The company has issued a recall of two lots of Fluorouracil Injections following concerns that these lots may contain glass particulate, which is harmful and potentially life-threatening to patients.

Fresenius Kabi issued the recall notification after finding glass particulate in a total of five vials of Fluorouracil Injections kept in the company’s sample inventory.  The lot number for these five vials is 6120341.  As such, Fresenius Kabi issued a recall of this particular lot, along with lot number 6120420, which was manufactured in the same filling campaign as the affected lot.

Specific Recall Information on Fresenius Kabi’s Fluorouracil Injections

Fresenius Kabi has provided the following information on the affected lots of Fluorouracil Injections subject to the recent voluntary recall:

Product Name/Size	NDC Number	Product Code	Lot Number	Expiration Date	First Ship Date	Last Ship Date
Fluorouracil Injection, USP 5g/100mL (50mg/mL), 100mL fill in 100mL vial	63323-117-69	NP101761	6120341	April 2020	12/6/18	12/18/18
	63323-117-61	101761	6120420	April 2020	12/7/18	2/20/19

 

Fresenius Kabi has not received any reports of injuries or death related to the affected lots which may contain glass particulate. However, given the serious nature of the impurity in the chemotherapy drugs, which patients rely on, Fresenius Kabi has proactively recalled the products to ensure no additional patients are exposed to the potentially harmful drugs.

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