Bottles of two medications that prevent the body's rejection of transplanted organs were recalled because the capsules may be empty.
Astellas Pharma US, Inc. announced this week it is voluntarily pulling one lot of PROGRAF 0.5mg and one lot of ASTAGRAF XL 0.5mg from consumer shelves because empty capsules that may be contained in the bottles could be fatal when taken by patients who have undergone organ transplants.
The medications - which were distributed nationwide to wholesale and retail outlets - are often used jointly with other medicines to prevent organ rejection, according to the pharmaceutical company's news release posted on the FDA website.
The multinational company's announcement said no reports of harmful effects related to this recall had been received at the time the news release was published.
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PROGRAF is used by patients who have had heart, kidney, lung or liver, or lung transplants and ASTAGRAF XL is specifically associated with kidney transplant patients.
Both are anti-rejection medications that help prevent the rejection of a transplanted organ or tissue in patients.
Taking an empty capsule could cause the body to start rejecting a transplanted organ or tissue.
For patients that have received life-saving organ transplants in cases where there is no substitute, such as in a heart transplant, the body's rejection of the transplanted organ can be fatal, according to the company's statement.
PROGRAF 0.5 mg capsules: 100 capsules in a bottle. The lot number is 0E353D with the expiration date of March 2026.
ASTAGRAF XL 0.5 mg capsules: 30 capsules in a bottle. The lot number is 0R3092A with the expiration date of March 2026.
No other dosages are affected, according to the news release. Astellas has a sufficient supply of the unimpacted product available to replace the recalled items, the company's announcement says.
The company issued letters notifying customers of the recall and is taking returns of the affected medications, Astellas officials said in the announcement.