The Food and Drug Administration (FDA) has ordered the recall of 10 lots of the antibiotic colistimethate and three lots of antibacterial drug Rifampin manufactured by Emcure Pharmaceuticals and distributed by Heritage because of manufacturing practices that put the injectable drugs’ sterility in question.
Intravenous administration of non-sterile injection products may result in a site-specific or systemic infection, which may lead to hospitalization, significant morbidity (such as organ damage), or death. To date, Heritage has not received any reports of adverse events in patients resulting from use of the injections affected by the recall.
Affected products include 10 lots of colistimethate injection, USP, 150 mg Single-dose vial (NDC 23155-193-31) and three lots of rifampin for injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure Pharmaceuticals and distributed by Heritage. The products were distributed to hospitals, wholesalers and distributors nationwide from December 2012 through January 2015 (colistimethate) and from October 2014 through January 2015 (rifampin) .
Colistimethate is used to treat acute or chronic infections due to sensitive strains of certain gram-negative bacteria. Rifampin is used to treat all forms of tuberculosis.
Medical facilities that have received the affected products have been notified and instructed to quarantine, discontinue distribution of and return the recalled products. Health care professionals and patients are encouraged to report any side effects involving these drugs to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.