Heritage Initiates a Voluntary Recall Due to a Lack of Sterility Assurance

FDA PRESS, FOR IMMEDIATE RELEASE — February 24, 2015 — Eatontown, NJ, Heritage Pharmaceuticals Inc. (Heritage) today announced the voluntary nationwide recall of ten (10) lots of Colistimethate for Injection, USP, 150 mg Single-Dose vial (NDC 23155-193-31) and three (3) lots of Rifampin for Injection, USP, 600 mg Single-Dose vial (NDC 23155-340-31) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Heritage. Both products are sold in single vial mono-cartons in case packs of ten (10). Heritage has initiated this voluntary recall of Colistimethate for Injection, USP, 150 mg Single-Dose vial and Rifampin for Injection USP, 600 mg Single-Dose vial to the user level due to FDA observations pertaining to aseptic and GMP practices at the manufacturer’s site potentially impacting product sterility.

Intravenous administration of non-sterile injection products to a normally sterile site may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity (permanent organ damage), or fatal outcome. To date, Heritage is not aware of any adverse patient events resulting from the use of the subject product lots.

The lot numbers with expiry date being recalled are: Colistimethate for Injection

Rifampin for Injection

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 indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacteria. Rifampin is indicated for the treatment of all forms of tuberculosis.