The FDA recently posted a recall announcement released by Astellas Pharma US regarding an urgent recall of one lot each of their PROGRAF and ASTAGRAF XL medications. Astellas Pharma says the recalled lots may contain empty capsules and could post a significant risk to transplant patients.
Astellas Pharma US made the announcement just two days before Christmas. The recall applies to one lot of ROPGRAF® 0.5mg (tacrolimus) and one lot of ASTAGRAF XL® 0.5mg (tacrolimus extended-release) capsules. Prograf (NDC # 0469-0607-73) is distributed in a white cardboard box holding a plastic bottle that contains 100 capsules. Each bottle of Astagraf XL (NDC # 0469-0647-73) contains 30 extended-release capsules and is also packaged in a white cardboard box. The lot number for the recalled Prograf is 0E3353D, and the lot number for the recalled Astagraf XL is 0R3092A. Both drugs have an expiration date of 03/2026.
The FDA classifies both drugs as immunosuppressive medicines. PROGRAF® 0.5mg (tacrolimus) is prescribed to prevent an immune reaction and subsequent transplant rejection in patients who have had kidney, heart, liver, or lung transplants. ASTAGRAF XL® 0.5mg (tacrolimus extended-release) is prescribed for the same purpose in patients who have had kidney transplants. Astellas Pharma US has not provided any details regarding the production error that resulted in the inclusion of empty capsules in the affected lots of medication.
Thus far, Astellas Pharma US has not received any reports of injury or adverse reaction pertaining to the recalled products. The recalled lots of Prograf and Astagraf XL are potentially dangerous for post-transplant patients because they may contain empty capsules. If a patient takes an empty capsule, they will miss their prescribed dose of immunosuppressive medication, thereby increasing their risk of having an immune reaction to their transplanted organ. Such an immune reaction could ultimately result in rejection of the transplanted organ. Such a rejection could prove fatal for some patients.
The company has sent a drug recall notification letter to all customers. Anyone in possession of the recalled medication should reach out to their doctor and pharmacist for a health evaluation and to arrange for a prompt replacement of the drug. No other lots of PROGRAF® 0.5mg (tacrolimus) and ASTAGRAF XL® 0.5mg (tacrolimus extended-release) capsules are included in the recall.
Anyone with questions or concerns about the recall can contact Astellas Medical Information at 1-800-727-7003. They are available Monday through Friday from 9 a.m. to 5:30 p.m., EST.
Patients and health care providers can report any new adverse health events related to taking PROGRAF® 0.5mg (tacrolimus) and ASTAGRAF XL® 0.5mg (tacrolimus extended-release) through the FDA’s MedWatch Online Voluntary Reporting Form.
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