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Medication Safety Alerts

Kalbitor® 10 mg/1 mL Vials Voluntary Recall


On March 21, 2017, Shire issued a voluntary recall of Kalbitor® 10 mg/1 mL vials. This recall was issued because particles were found in retention samples.

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 A1500009 exp. 01/31/19. To see if you received affected product, please check the lot number. The lot number is located on the back of the manufacturer’s carton and on the right-hand side of the manufacturer’s label on the vial. If you product is not from lot number A1500009, it is not affected by this recall. If your product is from lot number A1500009,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 us not carried by the CVS Caremark Mail Service Pharmacies.

If you are currently using Kalbitor 10 mg/1 mL vials and have questions regarding this recall, please call your doctor or call Shire toll-free at 1-800-828-2088 and select option 4 or visit You may also call the U.S. Food and Drug Administration toll-free at 1‑888‑INFO-FDA (1‑888-463-6332) or visit their web site at

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