Drug Safety Alerts

Midazolam 1 mg/mL 2 mL prefilled syringes - Class I Recall

1/10/18

On January 10, 2018, the United States Food and Drug Administration (FDA) issued a notice regarding a Class I recall of midazolam 1 mg/mL 2 mL prefilled syringes NDC # 76045-0001-20 manufactured by Fresenius Kabi. This recall was issued due to a report of two blister packages (secondary) labeled as midazolam injection containing syringes of ondansetron injection. A missed dose of midazolam may lead to ineffective sedation and/or anxiety related to patient recall of a surgical or diagnostic procedure. If a selection error occurs, a patient who may have received a pre-operative dose of ondansetron may inadvertently receive an additional dose of ondansetron. Dose-dependent serious cardiac arrhythmias may be observed with higher dosages of ondansetron in those patients with certain pre-existing cardiac conditions. Patients may also be at risk for serotonin syndrome. Serotonin syndrome is associated with increased serotonergic activity in the central nervous system. Most reports of serotonin syndrome have been associated with concomitant use of certain drugs, some commonly used during surgery, such as fentanyl. Some of the reported cases of serotonin syndrome were fatal.

This recall affects lot number 6400048 exp. 07/31/18. No other lot is affected by this issue. The affected lot went into distribution in the United States on May 12, 2017.

Midazolam is indicated for sedation, anxiety, and for induction of general anesthesia. Ondansetron is indicated for the prevention of nausea and vomiting associated with cancer chemotherapy treatments and for prevention of postoperative nausea and/or vomiting.Please note: This recall was originally issued to the retail-level on November 3, 2017. The FDA classified this as a Class I Recall on January 10, 2018.

CVS Caremark Response: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, please call Fresenius Kabi Quality Assurance at 1‑866‑716‑2459. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.accessdata.fda.gov/.