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Medication Safety Alerts

Ampicillin and Sulbactam for Injection Voluntary Recall

February 14, 2018

On February 14, 2018, the United States Food and Drug Administration (FDA) issued a notice regarding a voluntary recall of ampicillin and sulbactam for injection 1.5 g vials. This recall was issued because it could contain glass particles. Using product with glass particles could cause 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 AF0117001-A exp. 12/31/18. To see if you have affected product, please check the lot number. The lot number is on the right-hand side of the manufacturer’s label. If your product is not from lot number AF0117001-A, it is not affected by this recall. If your product is from AF0117001-A, 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: This product is not carried by the CVS Caremark Mail Service Pharmacies.

If you are currently using ampicillin and sulbactam for injection 1.5 g vials and have questions regarding this recall, please call your doctor or call AuroMedics Customer Service toll-free at 1-888-238-7880, Monday through Friday, 9:00 am to 5:00 pm (ET) and select option 1. 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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