Tacrolimus and Tacrolimus Extended-Release capsules
Product details
- Tacrolimus and Tacrolimus Extended-Release capsules
Company announcement
Astellas Pharma US, Inc. is voluntarily recalling one lot of PROGRAF® 0.5mg (tacrolimus) and one lot of ASTAGRAF XL® 0.5mg (tacrolimus extended-release) capsules because bottles may contain empty capsules.
The product was distributed nationwide.
No adverse events have been reported to date.
Risk:
Transplant patients who consume empty PROGRAF or ASTAGRAF XL capsules may experience initiation of rejection of the transplanted organ, tissue, or cells, due to underimmunosuppression. 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.
Impacted states: Nationwide
Products:
- PROGRAF® 0.5mg (tacrolimus) capsules
- ASTAGRAF XL® 0.5mg (tacrolimus extended-release) capsules
Contact
For more information, call 1-800-727-7003.