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

Summary

Company Announcement Date:: December 23, 2024
FDA Publish Date:: December 24, 2024
Product Type:: Drugs
Reason for Announcement:: Recall Reason Description

Bottles may contain empty capsules.
Company Name:: Astellas Pharma US, Inc.
Brand Name:: Brand Name(s)
Product Description:: Product Description

Tacrolimus and Tacrolimus Extended-Release capsules

Company Announcement

FOR IMMEDIATE RELEASE – NORTHBROOK, IL, Dec. 23, 2024 – Astellas Pharma US, Inc. (Head of US Commercial: Michael Petroutsas, “Astellas”) is voluntarily recalling one lot of PROGRAF® 0.5mg (tacrolimus) and one lot of ASTAGRAF XL® 0.5mg (tacrolimus extended-release) capsules to the consumer level. These products are being recalled 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. To date, Astellas has not received any reports of adverse events related to this recall.

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.

The affected lot numbers and expiration dates are:

PRODUCT DESCRIPTION	NDC	LOT NO.	EXP. DATE
PROGRAF® (tacrolimus) 0.5 mg capsules 100 capsules per bottle	0469-0607-73	0E3353D	03/2026
ASTAGRAF XL® (tacrolimus extended- release capsules) 0.5 mg capsules 30 capsules per bottle	0469-0647-73	0R3092A	03/2026

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.

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 during office hours 9 am to 5 pm (EST), Monday through Friday.

Patients that have an affected lot should contact their physician or healthcare provider. Patients and physicians with questions should contact Astellas Medical Information at 1-800-727-7003 During office hours from 9 am to 5:30 pm EST, Monday through Friday.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About PROGRAF® 0.5mg (tacrolimus)

Please see the accompanying Patient Information and full Prescribing Information, including Boxed Warning.

About ASTAGRAF XL® 0.5mg (tacrolimus)

Please see the Medication Guide and full Prescribing Information, including Boxed Warning.

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women’s health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.

Cautionary Notes

In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.