Voluntary nationwide recall: Prograf and Astagraf (Astellas – December)

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Astellas Pharma US, Inc. is recalling one lot of Prograf, lot 0E3353D, and one lot of Astagraf XL, lot 0R3092A. Prograf and Astagraf XL are used in conjunction with other medicines to help prevent organ transplant rejection.

These drugs are being recalled because bottles may contain empty capsules. Using empty capsules may result in organ transplant rejection that may be fatal.

To see if your medication was recalled, contact your doctor or pharmacy where you received it or visit the FDA website below. If you have an affected lot of Prograf or Astagraf XL, you should stop using the product and contact your pharmacy where you received it for a replacement.

As of Dec. 26, there had been no reports of adverse events related to this recall.

To learn more about this recall, you can take one or more of the steps below.

  • Talk to your doctor or pharmacist.
  • Call Astellas Medical Information at 1-800-727-7003. TTY users should call 711. Help is available Monday through Friday from 9 a.m. to 5:30 p.m. EST.
  • Visit the FDA website.

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