TOPIC: One Lot of PROGRAF 0.5mg (Tacrolimus) and One Lot of ASTAGRAF XL 0.5mg (Tacrolimus Extended-Release Capsules) by Astellas Pharma: Recall - Due to Bottles Shipped to U.S. May Contain Empty Capsules
AUDIENCE: Patient, Health Care Professional, Pharmacy, Transplantation, Cardiology, Nephrology, Hepatology, Pulmonology
ISSUE: Astellas Pharma US is recalling one lot of PROGRAF 0.5mg (tacrolimus) and one lot of ASTAGRAF XL 0.5mg (tacrolimus extended-release) capsules because bottles may contain empty capsules.
Risk Statement: Transplant patients who consume empty PROGRAF or ASTAGRAF XL capsules may experience initiation of rejection of the transplanted organ, tissue, or cells, due to underimmunosuppression. In the case of life sustaining organ transplants such as a heart transplant (for which there is no permanent substitute such as hemodialysis in the case of a failed kidney transplant) if the transplant fails, the consequences of rejection initiated by ingesting empty capsules may be fatal.
No other formulations or doses of the product are impacted, and sufficient supply of unaffected stock is available to replace the recalled lots. Product was distributed nationwide to wholesale and retail outlets.
To date, Astellas has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: PROGRAF and ASTAGRAF XL are immunosuppressive medicines, used in conjunction with other medicines, to help prevent organ transplant rejection. PROGRAF is used in people who have had kidney, heart, liver, or lung transplants and ASTAGRAF XL is indicated for use in people with kidney transplants.
RECOMMENDATIONS:
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Patients that have an affected lot should contact their physician or healthcare provider.
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Patients and physicians with questions should contact Astellas Medical Information at 1-800-727-7003.
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Astellas is notifying its customers via a drug recall notification letter and is arranging for the return of impacted product. Wholesalers or pharmacists with questions about the recall process should contact 1-877-575-3437.
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