Antibiotic Capsules Recalled

Golden State Medical Supply Inc is recalling numerous lots of rifampin capsules for exceeding a 5-parts-per-million interim limit for 1-methyl-4-nitrosopiperazine, according to the October 26, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were manufactured by Patheon Pharmaceuticals Inc in Ohio, packaged by Golden State Medical Supply in California, and distributed nationwide:

• rifampin capsules, 150 mg, packaged in 30-count bottles (NDC 51407-322-30), from lots GS036715, GS037569, GS038132, GS038665, GS038750, GS039565, GS039997, and GS040673 (Exp. 10/31/22); GS040674, GS041237, GS041652, GS042152, and GS043365 (Exp. 3/31/23); and GS045441, GS045677, and GS046111 (Exp. 2/29/24);
• rifampin capsules, 300 mg, packaged in 30-count bottles (NDC 51407-323-30), from lots GS041430 and GS041941 (Exp. 1/31/23); and GS041315, GS042991, GS043027, GS043367, GS043501, and GS044421 (Exp. 3/31/23);
• rifampin capsules, 300 mg, packaged in 60-count bottles (NDC 51407-323-60), from lots GS041431, GS041799, GS042287, GS042414, and GS042879 (Exp. 1/31/23); and GS041316, GS042992, GS043368, GS043579 (Exp. 3/31/23); and
• rifampin capsules, 300 mg, packaged in 100-count bottles (NDC 51407-323-01), from lots GS041429 and GS041877 (Exp. 1/31/23); and GS041317, GS043028, GS043366, and GS044422 (Exp. 3/31/23).

Golden State Medical Supply voluntarily initiated the recall October 6, 2022. On October 17, 2022, the FDA designated the recall 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 to treat tuberculosis and the meningococcal carrier state.