Injectable Antibiotics Recalled Due to Sterility Concerns
Heritage Pharmaceuticals Inc. is voluntarily recalling 10 lots of its 150 mg injectable colistimethate and 3 lots of its 600 mg injectable rifampin following FDA observations of aseptic practices at the manufacturer's site that could potentially affect the products' sterility.
Heritage Pharmaceuticals Inc. is voluntarily recalling 10 lots of its 150 mg injectable colistimethate and 3 lots of its 600 mg injectable rifampin following FDA observations of aseptic practices at the manufacturer's site that could potentially affect the products’ sterility.
Intravenous administration of non-sterile products may result in a site-specific or systemic infection, potentially leading to hospitalization, significant morbidity, or death. There are currently no reports of adverse events associated with the use of the recalled products, according to Heritage.
The affected lots of colistimethate and rifampin were distributed to hospitals, wholesalers, and distributors from December 2012 through January 2015 and October 2014 through January 2015, respectively. The affected products are both sold in single vial mono-cartons in case packs of 10.
A complete list of the recalled lots of the injectable antibiotics can be found on the FDA’s website.
Heritage has notified its customers to examine their inventory immediately and quarantine, discontinue distribution, and return any stock of the recalled lots. In addition, the manufacturer has instructed its customers to identify and notify any of their customers who may have received further distributed products.
Those with questions regarding this recall should contact Heritage’s customer call center at 1-866-901-1230 between 9 a.m. and 5 p.m. Eastern Standard Time, Monday through Friday.
In addition to contacting their health care professionals, patients who have experienced adverse reactions to the affected product should report them to the FDA’s MedWatch Adverse Event Reporting program. Patients can submit the form online at www.fda.gov/medwatch/report.htm, download it at www.fda.gov/MedWatch/getforms.htm, or call 1-800-332-1088 to request it. Completed paper forms can be returned to the address on the pre-addressed form or faxed to 1-800-FDA-0178.