Fresenius Kabi USA has issued a voluntary recall of Midazolam Injection, USP, 2 mg/2 mL in 2 mL prefilled single-use glass syringes. The blister packaging contains syringes containing and labeled as Ondansetron Injection, USP, 4 mg/2 mL. The affected lot is Lot 6400048.
Midazolam is a sedative used to alleviate anxiety before surgery and for induction of general anesthesia. Ondansetron is an antinausea drug, also sold under the brand name Zofran, that can be used to control postsurgical vomiting.
According to the FDA’s recall announcement, missing a dose of midazolam can lead to ineffective sedation and no reduction in anxiety. Using the syringes with ondansetron could mean that some patients received a double dose of ondansetron, which can cause cardiac arrhythmias in patients with pre-existing cardiac conditions.
Fresenius Kabi has notified its distributors and customers by letter. Any health-care facilities that have the affected lot are being told to stop distributing, dispensing, or using it and to return all units to Fresenius Kabi.
The company has not received any reports of adverse events related to this recall. Adverse reactions or problems experienced with the use of this product may be reported to Fresenius Kabi Medical Affairs or Vigilance departments at 1-800-551-7176, Monday through Friday, between 8:00 a.m. and 5:00 p.m. Central Standard Time, or via email at [email protected] or [email protected].
Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Complete and submit the report online at www.fda.gov/medwatch/report.htm, download the form at www.fda.gov/MedWatch/getforms.htm, or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.