FDA hammers Mylan sterile injectable plants for serious contamination issues

The recent recall of 8 lots of injectable cancer drugs, some of which Mylan ($MYL) made for client Pfizer ($PFE), was just a prelude to an FDA warning letter, it turns out. The agency today posted the letter, aimed at three plants in India that Mylan got in its deal for Agila Specialties two years ago. The FDA said it knew Mylan had only recently bought the plants when the inspections started last year, but said the company should have picked up on the contamination concerns before the FDA had to step in. The action led Mylan CEO Heather Bresch to issue a statement that the company was committed to high standards and would address the issues. Story | More

Suggested Articles

Turns out Procter & Gamble didn’t want Pfizer’s consumer health unit after all. But it did want Merck KGaA’s.

Private equity firm, in exclusive talks with Sanofi, says it'll invest to pump up Zentiva into an "independent European generics leader."

With suitor Takeda circling Shire, the Dublin-based target has pulled off a deal of its own.