Medicine recalls
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| The United States: Astellas Pharma US, Inc. issues voluntary nationwide recall of one lot of PROGRAF® 0.5mg (Tacrolimus) and one lot of ASTAGRAF XL® 0.5mg (Tacrolimus Extended-Release Capsules) because bottles shipped to U.S. may contain empty capsules |
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The United States Food and Drug Administration (FDA) announces that Astellas Pharma US, Inc. (Astellas) is voluntarily recalling one lot of PROGRAF® (tacrolimus) 0.5mg capsules, 100 capsules per bottle (lot number: 0E3353D) and one lot of ASTAGRAF XL® (tacrolimus extended-release) 0.5mg capsules, 30 capsules per bottle (lot number: 0R3092A) to the consumer level. These products are being recalled because bottles may contain empty capsules.
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.
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. To date, Astellas has not received any reports of adverse events related to this recall.
No other formulations or doses of the product are impacted, and sufficient supply of unaffected stock is available to replace the recalled lots. Products were distributed nationwide to wholesale and retail outlets.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/astellas-pharma-us-inc-issues-voluntary-nationwide-recall-one-lot-prografr-05mg-tacrolimus-and-one
In Hong Kong, Prograf Cap 0.5mg (HK-47471) and Advagraf Prolonged-release Hard Cap 0.5mg (HK-56596) are pharmaceutical products registered by Astellas Pharma Hong Kong Company Limited (Astellas). They are both prescription-only medicines. As confirmed by Astellas, the affected lots have not been imported into Hong Kong.
Ends/Friday, Dec 27, 2024
Issued at HKT 16:00
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