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Medication Safety Alerts

Bupivacaine HCl Injection 0.5% (5 mg/mL) 30 mL Single-Dose Vials Voluntary Recall

07/16/2015

On July 16, 2015, the United States Food and Drug Administration (FDA) issued a notice regarding voluntary recall of bupivacaine HCl injection 0.5% (5 mg/mL) 30 mL single-dose vials. This recall was issued because of reports of iron oxide particles in the solution. Iron oxide particles would appear as orange and black particles floating in the medication bottle. Using product with iron oxide particles may cause a delay in therapy and serious side effects.

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 38-515-DK exp. 02/01/16. The lot number may be followed by the additional numbers 01 to 99. To see if you received affected product, please check the lot number. The lot number is located on the bottom of the manufacturer’s label. If your product is not from lot number 38-515-DK it is not affected by this recall. If your product is from lot number 38-515-DK, 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: If you are currently taking bupivacaine HCl injection 0.5% (5 mg/mL) 30 mL single-dose vials, 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 bupivacaine HCl injection 0.5% (5 mg/mL) 30 mL single-dose vials and have questions regarding this recall, please call your doctor or call Hospira Medical Information toll-free at 1-800-615-0187. 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.accessdata.fda.gov/scripts.

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