The bottles of two recalled drugs might have empty capsules. That can cause death
Two drugs have been recalled because their capsules might be empty — and the consequences could be deadly.
Astellas Pharma’s Prograf gets prescribed after heart, liver, kidney or lung transplants. Astellas’ Astagraf XL gets prescribed after kidney transplants. Capsules devoid of the immunosuppressive medicines that should be there can’t help the body accept the organ, tissue and cells transplanted.
“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,” says Astellas’ risk statement on its recall notice.
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Not all Prograf and Astagraf XL on the market have been recalled. Recalled Prograf is 0.5 mg strength, in 100-count bottles from lot No. 0E3353D. The recalled Astagraf comes in 30-count bottles of 0.5 mg strength from lot No. 0R3092A. Both have the expiration date March 2026.
If you’re a wholesaler with recalled Prograf or Astagraf XL and have questions about the recall, call 877-575-3437, Monday through Friday, 9 a.m. to 5 p.m., Eastern time.
If you’re a patient with the recalled lot, call your prescribing medical professional. Patients and doctors with questions about the recall, should call Astellas at 800-727-7003, Monday through Friday, 9 a.m. to 5:30 p.m., Eastern time.
Anyone who feels they’re experiencing a medical problem from either drug needs to contact a medical professional. Then, contact the FDA’s MedWatch program either online or by calling 800-332-1088 to request a reporting form and mailing or faxing it back to the FDA at 800-221-0178.
