Sagent Pharmaceuticals is voluntarily recalling 6 lots of its atracurium besylate injection following FDA observations of practices at the manufacturer's site that could potentially affect the products' sterility.
Sagent Pharmaceuticals is voluntarily recalling 6 lots of its atracurium besylate injection following FDA observations of practices at the manufacturer’s site that could potentially affect the products’ sterility.
The intravenous medication is indicated as an adjunct to general anesthesia to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Two lots of the recalled product were 50 mg/5 mL single-dose vials, with lot numbers of VATA012 and VATA015, while the remaining 4 lots were 100 mg/10 mL multi-dose vials, with lot numbers of VATB012, VATB013, VATB014, and VATB017.
All of the affected products were distributed to hospitals, wholesalers, and distributors between February 2014 and February 2015.
Sagent has notified its customers to examine their inventory immediately and quarantine, discontinue distribution, and return any stock of the recalled lots. In addition, the manufacturer has instructed its customers to identify and notify any of their customers who may have received further distributed products.
The FDA noted that non-sterile injections can potentially lead to unsafe and even fatal infections, especially in immunocompromised patients.
Those with questions regarding this recall should contact Sagent’s customer call center at 1-866-625-1618 between 9 a.m. and 8 p.m. Eastern Standard Time, Monday through Friday.
In addition to contacting their health care professionals, patients who have experienced adverse reactions to the recalled product should report them to the FDA’s MedWatch Adverse Event Reporting program. Patients can submit the form online at www.fda.gov/medwatch/report.htm, download it at www.fda.gov/MedWatch/getforms.htm, or call 1-800-332-1088 to request it. Completed paper forms can be returned to the address on the pre-addressed form or faxed to 1-800-FDA-0178.