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Medication Safety Alerts

Amikacin Sulfate 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 amikacin sulfate injection 1 gram/4 mL (250 mg/mL) manufactured by Teva Pharmaceuticals. This recall was issued because of glass particles identified in one vial. Using product with glass particles could cause local irritation or swelling as well as blockage and clotting in blood vessels.

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 4750915 exp. 09/17. To see if you received product from these affected lots, please check the lot number. The lot number can be found on the manufacturer’s label on the vial and on the manufacturer’s carton. 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 lot numbers, 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 amikacin sulfate injection 1 gram/4 mL (250 mg/mL), 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 using amikacin sulfate injection 1 gram/4 mL (250 mg/mL and have questions regarding this recall, please call your doctor or call Teva Medical Information at toll-free at 1-888-838-2872 and select option 3 then option 4. You may also call the FDA consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit www.fda.gov.

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