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Medication Safety Alerts

Pantoprazole Sodium for Injection 40 mg 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 pantoprazole sodium for injection 40 mg. This recall was issued because it could contain glass particles. Using product that has 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 CPO170035 exp. 05/19. To see if you received product from these affected lots, please check the lot number. The lot number is on the left hand side of the manufacturer’s label. If your product is not from lot number CPO170035, it is not affected by this recall. If your product is from lot number CPO170035, 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: This product is not carried by the CVS Caremark Mail Service Pharmacies.

If you are currently taking pantoprazole sodium for injection 40 mg and have questions regarding this recall, please call your doctor or call the Aurobindo Customer Service toll-free at 1‑866-850-2876, Monday through Friday, 9:00 am to 5:00 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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