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Medication Safety Alerts

Vancomycin Hydrochloride for Injection Voluntary Recall

4/12/2017

On April 12, 2017, the United States Food and Drug Administration (FDA) issued a voluntary recall of vancomycin Hydrochloride for Injection, USP 10 grams 100 mL vial NDC # 00409-6510-01 manufactured by Hospira Inc., a Pfizer Company. This recall was issued because hair was found stuck to the stopper inside 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 591053A exp. 11/01/2017. To see if you have affected product, please check the lot number. The lot number can be found on the right hand side of the manufacturer’s label above the bar code on the vial. If your product is not from lot number 591053A, it is not affected by this recall. If your product is from lot number 591053A, 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:

Please note: This product is not carried by the CVS Caremark Mail Service Pharmacies.

If you are currently using vancomycin Hydrochloride for Injection, USP 10 grams 100 mL vial and have questions regarding this recall, please call your doctor or call Hospira Inc., a Pfizer Company toll-free at1-800-615-0187, Monday through Friday, 8:00 am through 7:00 pm (ET). 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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