Drug Safety Alerts

Kalbitor® 10 mg/1 mL Vials Patient-Level Recall

3/21/2017

On March 21, 2017, Shire issued a patient-level recall of Kalbitor^® 10 mg/1 mL vials. This recall was issued as a precautionary measure after receiving notification of particles discovered in retention samples. Shire has assessed that the risk to patients from using affected product is low.

This recall affects lot number A1500009 exp. 01/31/19. No other lots are affected by this recall.

CVS Caremark Response:

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

For more information about this recall, health care providers may contact Shire at 1-800-828-2088 and select option 4 or visit www.kalbitor.com. You may also contact the U.S. Food and Drug Administration at 1‑888‑INFO-FDA (1‑888-463-6332) or visit their web site at www.fda.gov.