Question of Sterility Leads to Recall of Muscle Relaxant

Sagent Pharmaceuticals Inc is recalling several lots of its atracurium besylate injection due to FDA observations at the manufacturing site that call into question the products’ sterility.

The recall affects 2 lots of atracurium besylate injection, USP, 50 mg/5 mL single-dose vials, as well as 4 lots of the 100 mg/10 mL multi-dose vials.

The product, which is used as an adjunct to anesthesia, was manufactured by Emcure Pharmaceuticals Ltd and distributed by Sagent. The product is designed to facilitate endotracheal intubation and provide skeletal muscle relaxation during surgery or mechanical ventilation.

As health care providers know, a nonsterile product that is delivered intravenously can place patients at increased risk of infection and can be fatal, especially in patients who are immunocompromised.

So far, Sagent has heard of any adverse events related to the products.

The lots affected are VATA012, VATA015 (50 mg/5 mL), VATB012, VATB013, VATB014, and VATB017 (100 mg/10 mL). These lots were sent to wholesalers, hospitals, and distributors across the country between February 2014 and February 2015.

Consumers who have the recalled products are advised to discontinue use immediately. Individuals are also encouraged to report any adverse effects to the FDA’s MedWatch Program online.