Sterile injectables maker Sagent Pharmaceuticals is recalling a product because of leaking bags. It is the second recall in about 9 months for the company, which relies mostly on contractors to manufacture its products.
Sagent ($SGNT) said Tuesday that it was voluntarily recalling two lots of zoledronic acid injection, a drug used to treat bone conditions like the rare Paget's disease. The company said it did an investigation after getting a complaint of four leaking bags of the product. No adverse reactions have been reported, but Sagent pointed out that when bags are compromised, there is a chance for sterility problems.
The company said its distributor DDN of Dohmen Life Science Services is notifying Sagent's distributors and customers about the recall. The lots were distributed between Oct. 9, 2013, and Feb. 18 of this year.
In June, Sagent recalled three lots of vecuronium bromide, a paralyzing agent used in surgery that was produced for it by Turkey-based MN Pharmaceuticals. It said that routine testing of stability samples at 18 months found an unacceptably high level of impurities. Again, no adverse reactions were reported, but the company said the impurities could lead to prolonged neuromuscular blockade for critically ill patients with renal failure.
Sagent has been one of the fastest growing generic drug companies since it was founded in 2006 to specialize on injectable drugs. Its strategy has been to work primarily with contractors for manufacturing, saying it provided flexibility. But with consolidation in the industry creating some challenges, the drug company announced last year it would spend $25 million to get full control of a new, 300,000-square-foot, FDA-approved facility in Chengdu, China, that it initially partnered on. It is the first manufacturing facility that Sagent owns. CEO Jeffrey M. Yordon mentioned the buyout of Actavis ($ACT) by Watson Pharmaceuticals at the time as one motivating factor to get into manufacturing. He said Sagent would be severing its relationship with Actavis by the end of this year.
- here's the announcement
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