Astellas Pharma Recalls PROGRAF and ASTAGRAF XL Capsules

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Astellas Pharma US announced on Dec. 23, 2024 that it is voluntarily recalling one lot of PROGRAF 0.5mg (tacrolimus) and one lot of ASTAGRAF XL 0.5mg (tacrolimus extended-release) capsules because some bottles may contain empty capsules. PROGRAF and ASTAGRAF XL are immunosuppressive drugs used to prevent organ transplant rejection.

The recalled lot information for PROGRAF—which is used in kidney, heart, liver, or lung transplants—is as follows:

• Product: PROGRAF (tacrolimus), 0.5 mg capsules, 100 capsules per bottle
• National Drug Code (NDC) Number: 0469-0607-73
• Lot Number: 0E3353D
• Expiration Date: 03/2026.

Recall information for ASTAGRAF XL—which is used in kidney transplants—is as follows:

• Product: ASTAGRAF XL (tacrolimus extended-release capsules), 0.5 mg capsules, 30 capsules per bottle
• NDC: 0469-0647-73
• Lot Number: 0R3092A
• Expiration Date: 03/2026.

The recalled lots were distributed nationwide to wholesale and retail outlets. Other product formulations or doses are not impacted by the recall. Astellas is notifying customers about the recall so that arrangements to return the product can be made.

According to Astellas, patients who receive empty capsules of the recalled product may have limitation of rejection of the transplanted organ, tissue, or cells. “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,” the company stated in the press release (1).

While the company states that, as of the date of the press release, no adverse events have been reported in association with the recall, adverse events may be reported to FDA via its MedWatch Adverse Event Reporting program.

FDA also announced a recall of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count by Alcon Laboratories on Dec. 23, 2024 (2). The eye drops are used to sooth burning and irritation from dry eyes. The company voluntarily recalled one lot—Lot 10101,NDC 0065-1432-06—because of foreign material found by a consumer inside a sealed single-use vial, which was determined to be fungal. The recalled lot has an expiration date of 2025/09. No adverse events had been reported as of the date of the recall notice.

“Fungal contamination of an ophthalmic product is known to potentially cause eye infections. If an infection occurs, it may be vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients,” the company stated in the press release (2).

References

1. FDA. 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. Press Release. Dec. 24, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/astellas-pharma-us-inc-issues-voluntary-nationwide-recall-one-lot-prografr-05mg-tacrolimus-and-one
2. FDA. Alcon Laboratories Issues Voluntary Nationwide Recall of One (1) Lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101), Due to Fungal Contamination. Press Release. Dec. 23, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/alcon-laboratories-issues-voluntary-nationwide-recall-one-1-lot-systane-lubricant-eye-drops-ultra-pf