Sagent Pharmaceuticals ($SGNT), which relies primarily on contract manufacturers, is recalling a paralyzing agent used in surgery that is manufactured at a plant in Turkey. The company said testing found a high level of impurities.
The FDA and the company said Monday that Sagent was recalling three lots of 10 mg Vecuronium Bromide, an injectable drug produced for it by Mustafa Nevzat Ilac Sanayii, also called MN Pharmaceuticals. The contract manufacturer has 8 plants in Turkey. Vecuronium Bromide is used as a neuromuscular blocking agent during anesthesia to help with endotracheal intubation and to relax patients during surgery or mechanical ventilation.
Routine testing of stability samples at 18 months found an unacceptably high level of impurities. Sagent said it had not been informed of any adverse reactions but that the problem could lead to prolonged neuromuscular blockade for critically ill patients with renal failure.
Sagent's strategy has been to work primarily with contractors for manufacturing. CEO Jeffrey M. Yordon said last month in an interview that the company has 48 partners in 23 countries, providing it with flexibility. But with consolidation in the industry creating some challenges, Yordon announced last month that Sagent would spend $25 million to buy the 50% interest in a new, 300,000-square-foot, FDA-approved facility in Chengdu, China, it does not currently own. It is the first manufacturing facility that Sagent owns. The news came at the same time that it reported it would be ending its relationship with the former Watson Pharmaceuticals after its buyout of Actavis ($ACT). Yordon estimated contractors will continue to produce 80% of the company's products.
- here's the recall notice