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Voluntary nationwide recall: Prograf and Astagraf (Astellas – December)
UPMC Health Plan·Transplant Surgery, Pharmacy, Nephrology +1 more·Pharmacy
Effective date
Dec 26, 2024
We identified it
Aug 7, 2026
Summary
Astellas Pharma is recalling two specific lots of transplant rejection prevention medications (Prograf lot 0E3353D and Astagraf XL lot 0R3092A) due to bottles containing empty capsules, which could result in organ transplant rejection. Billing teams must alert providers and patients to verify medication lot numbers and coordinate replacements through pharmacies to prevent claims for ineffective medication and potential adverse outcomes.
Action Required
Immediately: Clinical and billing staff must identify all patients currently prescribed Prograf or Astagraf XL. Contact affected patients and their prescribing providers to verify medication lot numbers against the recalled lots (0E3353D for Prograf and 0R3092A for Astagraf XL). For patients with recalled lots: (1) Coordinate with pharmacy for immediate medication replacement before next dose, (2) Flag patient records in billing system to prevent duplicate billing for replacement medication, (3) Document lot number verification in patient chart. Billing team must be prepared to adjust claims if patients received non-therapeutic doses from recalled lots. As of December 26, no adverse events have been reported, but vigilance is critical given the fatal risk of transplant rejection. Contact Astellas Medical Information at 1-800-727-7003 (TTY: 711, Monday-Friday 9am-5:30pm EST) for additional guidance.