Sagent Pharmaceuticals, Inc. is recalling Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL after the U.S. Food and Drug Administration (FDA) raised concerns about production practices at the manufacturer's site.
The company said that it had launched a voluntary nationwide 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) to the user level. The products were manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent.
This action comes after FDA observations relating to aseptic and GMP practices at Emcure's facility that potentially impacted product sterility.
Sagent noted that non-sterility of a drug administered intravenously has the potential to result in infections, which could be fatal, especially in patients with compromised immune systems.
However, Sagent stressed that it is not aware of any patient becoming unwell as a result of using the recalled product lots.
The company has now transferred manufacturing of the product to its own facility.
The lot numbers being recalled are VATA012 and VATA015 (50mg/5mL) and VATB012, VATB013, VATB014 and VATB017 (100mg/10mL), which were distributed to hospitals, wholesalers and distributors across the United States 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.