FDA concerns about aseptic and GMP practices at a manufacturer's site "potentially impacting product sterility" has prompted another recall this week.
FDA is reporting that Heritage Pharmaceuticals Inc. has voluntarily recalled 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.
According to the report, the products distributed by Heritage are sold in single-vial mono-cartons in case packs of ten (10).
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), the agency reports. While "intravenous administration of non-sterile injection products to a normally sterile site may result in a site-specific or systemic infection," FDA reports, Heritage has not heard of any adverse patient events resulting from the use of the subject product lots.
This week FDA also announced that Sagent Pharmaceuticals Inc. was voluntarily recalling two lots of Atracurium Besylate Injection, USP, 50mg/5mL single-dose vials (NDC 25021-659-05) and four lots of Atracurium Besylate Injection, USP, 100mg/10mL multi-dose vials (NDC 25021-672-10) manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent.