Heritage Pharmaceuticals announced a voluntary nationwide recall of 10 lots of Colistimethate for Injection 150mg, and three lots of Rifampin for Injection 600mg. The recall is following observations by the Food and Drug Administration (FDA) regarding aseptic and GMP practices at the manufacturer’s site that could affect product sterility.
Colistimethate is a surface active agent which penetrates into and disrupts the bacterial cell membrane. Rifampin is a semisynthetic antibiotic that inhibits DNA-dependent RNA polymerase activity in susceptible Mycobacterium tuberculosis organisms. Specifically, it interacts with bacterial RNA polymerase but does not inhibit the mammalian enzyme. Intravenous administration of non-sterile injectables may lead to local or systemic infection, which may result in hospitalization, significant morbidity, or fatal outcome.
The affected products are sold as single-dose vials in 10-count mono-cartons. The Colistimethate for Injection has NDC #23155-193-31 and Rifampin for Injection has NDC #23155-340-31. The full list of recalled products can be found here.
For more information call (800) 505-9291 or visit HeritagePharma.com.