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Patient Safety Notice: Astellas recall of certain lots of immunosuppressant capsules

Published on: Friday, December 27, 2024

Astellas Pharma US has issued a voluntary recall notice for one lot of PROGRAF® (tacrolimus) 0.5 mg capsules and one lot of ASTRAGRAF XL® (tacrolimus extended-release) 0.5 mg capsules because bottles in the affected lots may contain empty capsules. The specific lot numbers are displayed below, as well as in this announcement on the FDA.gov website.

  • PROGRAF® (tacrolimus) 0.5 mg capsules, NDC 0469-0607-73, Lot # 0E3353D, Expiration date 03/2026
  • ASTRAGRAF XL® (tacrolimus extended-release) 0.5 mg capsules, NDC 0469-0647-73, Lot # 0R3092A, Expiration date 03/2026

No other formulations or doses of the product are affected, and the manufacturer reports a sufficient supply of unaffected stock is available to replace the recalled lots.

Patients and physicians who have further questions should contact Astellas Medical Information at 1-800-727-7003 during office hours from 9 a.m. to 5:30 p.m. EST, Monday through Friday. Additional information is available in the announcement on the FDA website.