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Medication Safety Alerts

Midazolam 1 mg/mL 2 mL prefilled syringes - Voluntary Recall

January 10, 2018

On January 10, 2018, the United States Food and Drug Administration (FDA) issued a notice regarding a voluntary recall of midazolam 1 mg/mL 2 mL prefilled syringes manufactured by Fresenius Kabi. This recall was issued because packages labeled as midazolam injection could contain ondansetron injection. Using ondansetron injection instead of midazolam injection could cause serious side effects.

This may represent a potential health hazard or safety risk to plan members who may be using product affected by this recall.

This recall affects lot number 6400048 exp. 07/31/18. To see if you have affected product, please check the lot number. The lot number is on the manufacturer’s carton above the barcode. If your product is not from lot number 6400048, it is not affected by this recall. If your product is from lot number 6400048, please contact the pharmacy that filled your prescription for further instructions.

You should not continue to use product that is affected by this recall. Please call your doctor right away for advice if you may be using affected product. Your doctor is familiar with your medical history and can suggest the best treatment option for you. If you need a prescription for a different medicine, please call your doctor.

CVS Caremark Response: This product is not carried by theCVS Caremark Mail Service Pharmacies. If you are currently taking midazolam 1 mg/mL 2 mL prefilled syringes, please call a Customer Care representative toll-free at 1-866-823-5184 for more information.

If you are currently using midazolam 1 mg/mL 2 mL prefilled syringes and have questions regarding this recall, please call your doctor or call Fresenius Kabi Quality Assurance toll-free at 1‑866‑716‑2459You may also call the FDA consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.accessdata.fda.gov.

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