Heritage and Sagent Pharmaceuticals recalled their products due to sterility concerns

Sagent and Heritage pharmaceuticals are voluntarily recalling their products following FDA observations of practices at the manufacturer’s site that could potentially affect the products’ sterility. Heritage Pharmaceuticals Inc. is recalling 10 lots of its 150 mg injectable colistimethate and 3 lots of its 600 mg injectable rifampin and Sagent Pharmaceuticals is recalling 6 lots of its atracurium besylate (muscle relaxant) injection. Among the 6 lots of atracurium besylate two lots were 50 mg/5 mL single-dose vials, with lot numbers of VATA012 and VATA015, while the remaining 4 lots were 100 mg/10 mL multi-dose vials, with lot numbers of VATB012, VATB013, VATB014, and VATB017. All the Lots are distributed between February 2014 and February 2015. The affected lots of Sagent’s colistimethate and rifampin were distributed to hospitals, wholesalers, and distributors from December 2012 through January 2015 and October 2014 through January 2015, respectively. Both the companies have notified their customers to return product from any 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.