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Medication Safety Alerts

Bupivacaine hydrochloride injection (2.5 mg/mL) 0.25% vials Voluntary Recall

12/28/2016

On December 28, 2016, the United States Food and Drug Administration (FDA) issued a notice regarding a voluntary recall of bupivacaine hydrochloride injection (2.5 mg/mL) 0.25% vials. This recall was issued because particle matter was found in a single 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 number 59-064-DK exp. 11/01/17. To see if you have affected product, please check the lot number. The lot number can be found on the bottom of the manufacturer’s label. If your product is not from lot number 59-064-DK, it is not affected by this recall. If your product is from lot number 59-064-DK, 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 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: This product is not carried by the CVS Caremark Mail Service Pharmacies.

If you are currently using bupivacaine hydrochloride injection (2.5 mg/mL) 0.25% vials and have questions regarding this recall, please call your doctor or call Hospira Medical Communications toll-free at 1-800-615-0187. You may also call the FDA consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.accessdata.fda.gov.

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