Astellas Pharma and Endo subsidiary Endo USA issued voluntary recalls for products they manufacture over concerns of empty tablets and unapproved ingredients, respectively.
The recall letters for both companies were posted on the enforcement page of the FDA's website.
Astellas, which issued its notice Dec. 23, is 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.
Both Prograf and Astagraf are immunosuppressants typically prescribed to organ transplant patients to help prevent their immune systems from rejecting a new organ.
“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,” the company said. “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.”
As of the filing with the FDA, Astellas had not received any reports of adverse events related to the recall.
In the case of Endo, the company issued its recall Dec. 20 for all unexpired lots of Adrenalin chloride solution (epinephrine nasal solution) 30mg/30mL vials, which is used as a vasoconstrictor for topical application.
The product, which predates the Federal Food, Drug and Cosmetic Act of 1938, has never been submitted to the agency for review and is considered “unapproved” and subject to recall, according to the announcement.
In its notice, the company said the FDA considers the product “misbranded” and having a misleading label that is similar in appearance to the approved product Adrenalin (epinephrine injection), which Endo also manufactures.
The lots being recalled were distributed nationwide in the U.S. to wholesale distributors from Oct. 10, 2023, through Dec. 11, 2024.
Although no reports of adverse effects from the product have been reported, the company said patients receiving the wrong dose of epinephrine in emergency situations may be at risk of death.