Tuberculosis Drug Recalled

Akorn Inc is recalling 195,584 bottles of rifampin capsules due to an impurity. According to the October 5, 2022, US Food and Drug Administration (FDA) Enforcement Report, the capsules exceed the interim limit for 1-methyl-4-nitrosopiperazine.

The recall affects the following rifampin products, which were distributed by Akorn Operating Company, Gurnee, IL, throughout the United States and in Puerto Rico:

• rifampin capsules, 150 mg, 30-count bottles (NDC 61748-015-30), from lots 3192818 (Exp. 10/31/22), 3199700 (Exp. 3/31/23), and 3203853 (Exp. 2/29/24);
• rifampin capsules, 300 mg, 30-count bottles (NDC 61748-018-30), from lots 3192827 (Exp. 10/31/22), 3196136 (Exp. 12/31/22), 3202198 (Exp. 7/31/23), 3203658 (Exp. 7/31/23), 3209114 (Exp. 11/30/23), and 3203851 (Exp. 2/29/24);
• rifampin capsules, 300 mg, 60-count bottles (NDC 61748-018-60), from lots 3191254 (Exp. 9/30/22), 3192820 (Exp. 9/30/22), 3192822 (Exp. 10/31/22), 3192824 (Exp. 10/31/22), 3192825 (Exp. 10/31/22), 3196141 (Exp. 1/31/23), 3196143 (Exp. 2/28/23), 3203870 (Exp. 11/30/23), and 3203871 (Exp. 02/29/24); and
• rifampin capsules, 300 mg, 100-count bottles (NDC 61748-018-01), from lots 3190636 (Exp. 9/30/22), 3192813 (Exp. 9/30/22), 3196132 (Exp. 12/31/22), 3196133 (Exp. 12/31/22), 3196138 (Exp. 1/31/23), 3199702 (Exp. 3/31/23), and 3199703 (Exp. 3/31/23).

Akorn voluntarily initiated the recalls September 21, 2022. On September 28, 2022, the FDA designated them Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Rifampin is a prescription antibiotic used in the treatment of tuberculosis.