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Medication Safety Alerts

Methotrexate Injection 50 mg/2 mL 2 mL single-dose vials Voluntary Recall

8/20/2015

On August 20, 2015, the United States Food and Drug Administration (FDA) issued a notice regarding a voluntary recall of methotrexate injection 50 mg/2 mL 2 mL single-dose vials manufactured by Mylan Institutional and distributed by Mylan or Pfizer. This recall was issued because particles were found during sample testing.

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

A complete list of the affected products and lot numbers is provided here:

To see if you have affected product, please check the lot number. The lot number is located on the back of the manufacturer’s label by the bar code. If your product is not from one of the affected lots, it is not affected by this recall. If your product is from one of the affected lots, please return it to the pharmacy that filled your prescription.

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:

Please note: These products are carried by the CVS/caremark Specialty Pharmacies only. If you received product affected by this recall, please call your Specialty pharmacy toll-free at the number on your prescription label. We will give you more information and help with arrangements for the return and replacement of any affected product. We will give you more information and help with arrangements for the return and replacement of any affected product.

If you are currently taking methotrexate Injection 50 mg/2 mL 2 mL single-dose vials manufactured by Mylan Institutional and have questions regarding this recall, please call your doctor or call Mylan Institutional toll-free at 1-800-796-9526, Monday through Friday, 8:00 am through 5:00 pm (ET). You may also call the FDA consumer inquiry line toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit their Web site at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-1328-2015&w=08192015&lang=eng

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