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Medication Safety Alerts

Gemcitabine for Injection Voluntary Recall

8/31/2015

On August 31, 2015, the United States Food and Drug Administration (FDA) issued a notice regarding a voluntary recall notice on gemcitabine for injection 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 box the product came in and the manufacturer’s label. 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.

Please call your doctor right away for advice if you may be using affected product or if you do not know if you used affected product or not. 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 not carried by the CVS/caremark Mail Service Pharmacies.

For more information, please call Mylan Institutional toll-free at 1-800-796-9526, Monday through Friday, 8:00 am through 5:00 pm (ET) or visit https://www.mylan.com. 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.fda.gov/Safety.

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