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Medication Safety Alerts

Hydromorphone HCl Injection Voluntary Recall

March 21, 2018

On March 21, 2018, the United States Food and Drug Administration (FDA) issued a notice regarding voluntary recalls of hydromorphone hydrochloride injection C-II 10 mg/mL 1 mL single-dose vials manufactured by Hospira (a Pfizer company) and distributed by Hospira and Teva Pharmaceuticals. This recall was issued because some vials may be empty or cracked at the bottom of the glass vial. Cracks in the vials could cause cuts or affect the sterility of the product which could cause infections 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.

A complete list of the affected products and lot numbers is provided here:

To see if you have affected product, please check the lot number that appears on the manufacturer’s label on your vials.

Hospira label: The lot number is located on the manufacturer’s label.

Teva label: The lot number is located on the right hand side of the manufacturer’s label by the barcode.

If your product is not from one of these affected lot numbers, it is not affected by this recall. If your product is from one of these affected lot numbers, 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:

These products are not carried by theCVS Caremark Mail Service Pharmacies. If you received recalled product from your retail pharmacy, please contact the pharmacy that filled your prescription for further instructions.

If you are currently using hydromorphone hydrochloride injection C-II 10 mg/mL 1 mL single-dose vials and have questions regarding this recall, please call your doctor or call Pfizer Safety toll-free at 1-800-438-1985. You may also call the FDA consumer inquiry line toll-free at 1‑888‑INFO-FDA (1‑888-463-6332).

To view the FDA recall notice regarding this recall, please click on the link below:

https://www.fda.gov/Safety/Recalls/ucm599442.htm.

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