Immunosuppressant Recalled
Ascend Laboratories is recalling 117 493 bottles of mycophenolic acid delayed-release tablets after samples failed to meet dissolution specifications, according to the October 2, 2024, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects mycophenolic acid delayed-release tablets, 360 mg, in 120-tablet bottles (NDC 67877-427-12) from the following lots:
- 22123437, 22123438, and 22123535 (Exp. 9/30/24);
- 22123536, 22123537, 22123538, 22123646, and 22123647 (Exp. 10/31/24);
- 23120529 and 23120530 (Exp. 1/31/25);
- 23120703 and 23120705 (Exp. 2/28/25);
- 23121429, 23121726, 23122049, and 23122097 (Exp. 4/30/25);
- 23121984, 23121985, and 23121986 (Exp. 5/31/25);
- 23122325, 23122329, 23122330, and 23122331 (Exp. 6/30/26);
- 23122776, 23122852, 23122853, 23123154, and 23123155 (Exp. 8/31/26); and
- 23123458 (Exp. 9/30/26).
The tablets were manufactured by Alkem Laboratories, Ltd., India, and distributed by Ascend Laboratories, Parsippany, New Jersey, in the United States and Puerto Rico.
Ascend Laboratories voluntarily initiated the recall on September 3, 2024. On September 24, 2024, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Mycophenolic acid is a prescription immunosuppressant used for prophylaxis of organ rejection after a kidney transplant.
