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Medication Safety Alerts

Irbesartan containing products Voluntary Recall

January 18, 2019

On January 18, 2019, Solco Healthcare U.S. issued a voluntary recall of irbesartan containing products including:

  • irbesartan
  • irbesartan hydrochlorothiazide (HCTZ) tablets.

This recall was issued because an unexpected impurity was found in these products that may cause a potential safety risk to plan members who may be using products affected by this recall.

The recall affects the following products and lot numbers:

If your product was dispensed in the manufacturer’s bottle, please check the lot number. The lot number is on the manufacturer’s label on the right-hand side. If your product is not from one of these affected lots, it is not affected by this recall. If your product is from one of these affected lots or if your product was dispensed in a pharmacy’s vial, please contact the pharmacy that filled your prescription for more information including return instructions.

Please note: The United States Food and Drug Administration (FDA) recommends that members should continue taking their medication until their pharmacist provides a replacement, or their doctor prescribes a different medication that treats the same condition. The risk of harm to a member’s health may be higher if the treatment is stopped immediately without any alternative treatment. 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 contact your doctor.

CVS Caremark Response: If you are currently taking irbesartan or irbesartan/HCTZ tablets, please call a Customer Care representative toll-free at 1-866-823-5184. We will give you more information and help with arrangements for the return and replacement of any affected product.

For more information regarding this recall, please call your doctor or call Solco Healthcare U.S. toll-free at 1-866-931-9829.You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit www.fda.gov.

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