Antibiotic Injection Recalled

Mylan Pharmaceuticals Inc is recalling 33,893 vials of rifampin for injection because of high, out-of-specification results for a compound detected during stability testing. The recall was included in the April 27, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects rifampin for injection, 600-mg vials (NDC 67457-445-60), from lots 7008990 (Exp. 12/22), 7009025 (Exp. 2/23), and 7009085 and 7009086 (Exp. 4/23). The product was manufactured for Mylan Institutional, Morgantown, WV, and distributed throughout the United States.

Mylan Pharmaceuticals voluntarily initiated the recall April 7, 2022. On April 15, 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 for injection is a prescription medication used to treat tuberculosis and the meningococcal carrier state.