Sagent announced its voluntary nationwide recall of two lots of Atracurium Besylate Injection 50mg/5mL single-dose vials and four lots of Atracurium Besylate Injection 100mg/10mL multi-dose vials.
The recall is following observations by the FDA regarding aseptic and GMP practices at the manufacturer’s site that may potentially affect product sterility.
Atracurium Besylate Injection is a nondepolarizing neuromuscular blocker indicated as adjunct to general anesthesia to facilitate endotracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Intravenous administration of a non-sterile drug may lead to fatal infections, especially in patients who are immunocompromised.
The affected products have Lot # VATA012, VATA015 for the 50mg/5mL strength, and VATB012, VATB013, VATB014, VATB017 for the 100mg/10mL strength. Sagent has transferred the product manufacturing to its own facility. Customers are being notified of arrangements to return all recalled products.
For more information call (866) 625-1618 or visit FDA.gov.
This article originally appeared on MPR