FDA: Recall of prefilled syringes labeled Midazolam that are actually Ondansetron

Editor's Note

The FDA announced on November 3 that Fresenius Kabi USA (Lake Zurick, Illinois) is recalling one lot of Midazolam Injection, USP, 2 mg/2 mL packaged in 2 mL prefilled single-use glass syringes because the packages labeled as Midazolam actually contain syringes that are filled with and labeled as Ondansetron Injection, USP, 4 mg/2 mL.

Midazolam is indicated for sedation, anxiety, and induction of general anesthesia, and Ondansetron is indicated for the prevention of postoperative nausea and vomiting.

The affected lot is 6400048. The company has not received any reports of adverse events related to this recall.

Posted 11/03/2017] AUDIENCE: Pharmacy, Surgery, Risk Manager ISSUE: Fresenius Kabi USA is voluntarily recalling Lot of Midazolam Injection, USP, 2 mg/2 mL packaged in a 2 mL prefilled single-use glass syringe to the hospital/user level. The product mislabeled as Midazolam Injection, USP, 2 mg/2 mL contains syringes containing and labeled as Ondansetron Injection, USP, 4 mg/2 mL.

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