Fresenius Kabi Recalls Midazolam Injection, USP, 2 mg/2
The voluntary recall is due to blister packages containing the incorrect product.
On Nov. 3, 2017, Fresenius Kabi USA voluntarily recalled Lot 6400048 of Midazolam Injection, USP, 2 mg/2 mL packaged in a 2-mL prefilled single-use glass syringe to the hospital/user level. The lot was recalled because the package incorrectly contained syringes labeled as Ondansetron Injection, USP, 4 mg/2 mL.
Midazolam is used for sedation, anxiety, and for induction of general anesthesia. While the company had not received any reports of adverse events as of November 3, missing a dose of midazolam “may lead to ineffective sedation and/or anxiety related to patient recall of a surgical or diagnostic procedure.” In addition, if the patient is given an additional dose of ondansetron, according to the company, cardiac arrhythmias may occur. Also, serotonin syndrome may also occur, which may be fatal.
The recalled lot expires July 2018 and was distributed nationwide between May 12, 2017 and Oct. 18, 2017. Healthcare facilities are advised to immediately discontinue distribution and use of the lot and return the product to Fresenius Kabi. Adverse events can be reported to FDA via the agency’s website.
Source: FDA
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
