
Sagent Pharmaceuticals Recalls Atracurium Besylate Injection
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
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.
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