A Texas-based compounder which has been fighting FDA efforts to force a recall of its products for several years has finally caved.
According to an FDA notice Wednesday, Downing Labs is voluntarily recalling all lots of sterile products distributed in the U.S. and the U.K. that have yet to expire because of "concerns over sterility assurance." The products were distributed between April 20, 2015, and Sept. 15, 2015, the notice says.
The recall comes after another inspection of the Dallas-based company. In a Form 483 the FDA posted last week, the agency noted 7 lots where there had been failures of sterility testing and accused the company of not thoroughly investigating the failures.
The FDA got more oversight over compounders in 2013 after passage of the Drug Quality and Security Act, that was passed following an meningitis outbreak tied to a compounder. Even before that, the FDA was concerned but for several years the company refused FDA requests that it recall its products. In September 2014, the FDA issued a warning to providrs that the company couldn't affirm its products were safe and that providers were taking a chance by using them. Included in the warning was a link to its letter to the Dallas-based operation asking the company to voluntarily recall its products and laying out a list of problems it said it discovered at the facility during an inspection that ran over 5 weeks last year.
The FDA said the inspection determined that 19 lots of purportedly sterile drugs "tested positive for microbial contamination. In addition, three lots failed endotoxin testing." The FDA said that may be the result of poor aseptic filling processes and because APIs coming into the facility were contaminated with endotoxins.
But in a response on its website, the company said the 19 lots were never released and that it would happily provide testing results and reports indicating that any lots that failed were destroyed. The company outlined a long list of changes it has made in response to FDA concerns. It switched to an FDA-approved testing lab, changed gowning procedures and relocated and added HEPA filters in clean rooms. It said it is making changes that are outside the requirements of compounders to better serve its customers.
- here's the recall notice
- here's the Form 483