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Medication Safety Alerts

8.4% Sodium Bicarbonate Injection Voluntary Recall

06/01/2016

On June 1, 2016, the United States Food and Drug Administration (FDA) issued a notice regarding a voluntary recall of 8.4% Sodium Bicarbonate Injection 50mEq (1mEq/mL) 50 mL single-dose vial manufactured by Hospira Inc. This recall was issued due to presence of particulate matter identified in one vial.

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 number56-148-EV exp. 08/01/17.To see if you received product from these affected lots, please check the lot number. The lot number can be found on the bottom right-hand side of the manufacturer’s label. If your product is not from this affected lot, it is not affected by this recall. If your product is from this affected lot, 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: If you are currently using 8.4% Sodium Bicarbonate Injection 50mEq (1mEq/mL) 50 mL single-dose vial, 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.

If you are currently taking 8.4% Sodium Bicarbonate Injection 50mEq (1mEq/mL) 50 mL single-dose vial and have questions regarding this recall, please call your doctor or call Hospira Customer Service toll-free at 1-877-946-7747. 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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