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The company voluntarily recalls product due to FDA observations of potential sterility problems.
FDA announced on Feb. 23, 2015 that Sagent Pharmaceuticals has issued a voluntary recall of 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. The recall comes after FDA observed aseptic and GMP practices at the Schaumburg, IL facility that could impact product sterility. Sagent has moved production of the product to its own facility.
Affected lot numbers include VATA012, VATA015 (50mg/5mL), and VATB012, VATB013, VATB014, VATB017 (100mg/10mL), which were distributed to hospitals, wholesalers, and distributors nationwide from February 2014 through February 2015. Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation, and is supplied in single-dose and multi-dose vials.
According to Sagent, no adverse patient events have occurred with use of the product. FDA states that non-sterility of intravenous drugs could result in potentially fatal infections.