> Mylan, after initially recalling just 15 lots of valsartan-based drugs that it says were tainted by a carcinogen, has now expanded its consumer-level voluntary nationwide recall to include all 104 lots of valsartan-containing products within expiry. Release
> Boehringer Ingelheim has sold its synthetic API plant to Japan’s AGC which will now have its first FDA-approved facility in Europe in the CDMO business. Release
> After putting South Korea’s Barox on its import alert list, the FDA has issued a warning letter to the OTC repackager. Warning letter
> The FDA has issued a Form 483 to Gadea Biopharma in Leon, Spain, after an inspection of the sterile drug manufacturer lacked some of the basic processes for producing drugs. Form 483