Drug Safety Alerts

Fluorouracil Injection Class I Recall

07/24/2019

On July 24, 2019, the United States Food and Drug Administration (FDA) issued a notice regarding a Class I recall of Fluorouracil Injection products manufactured by Fresenius Kabi. This recall was issued as a precautionary measure due to the potential for glass particulate.

A complete list of the affected following products and lot numbers is provided here:

The administration of glass particulate, if present in a parenteral drug, poses a moderate safety risk to patients. Reports in the literature suggest that sequelae of thromboembolism, such as pulmonary emboli, phlebitis, granulomas, or fibrosis may occur. Affected product started shipping December 06, 2018.

Products containing glass particulate should not be administered intravenously due to the potential for life-threatening consequences. To date, Fresenius Kabi has not received any complaints or reports of adverse events related to this recall.

CVS Caremark^® Response:

Please note: These products are not carried by CVS Caremark Mail Service Pharmacies.

For more information about this recall, please contact Fresenius Kabi at 1-800-551-7176. You may also contact the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.