The US Food and Drug Administration (FDA) has classified a voluntary Class I recall from Fresenius Kabi, a Lake Zurich, Illinois-headquartered specialty and generic pharmaceuticals company and a subsidiary of Fresenius KGaA, a Bad Homburg, Germany-headquartered healthcare group, that the company initiated in October 2017 for 203,136 prefilled syringes. The notice was posted in the US Food and Drug Administration January 10, 2018 Weekly Enforcement Report.

Fresenius initiated the recall because of a label mix-up, according to the FDA. The blister packages labeled as midazolam injection, USP, 2 mg / 2 ml, contained syringes of ondansetron injection, USP, 4 mg / 2 mL.

Midazolam is a sedative used to help patients feel relaxed or sleepy before surgery or medical procedures. Ondansetron injection is used to prevent nausea and vomiting caused by cancer chemotherapy and surgery.

A Class I recall occurs when the product deficiency is potentially life-threatening or could cause a serious risk to health.

Source: FDA