An Indian chemical plant that supplied the active ingredients in generic Viagra and Cialis to American compounding pharmacies has recalled everything it had in US distribution after federal inspectors documented residue-covered equipment, an employee in open-toed sandals beside open production lines, and laboratory paperwork the company could not substantiate.
The warning letter to Shoolin Pharma Chem LLP, issued August 18 and posted September 1, describes a Gujarat facility that made sildenafil citrate and tadalafil for the US market. The FDA declared the products adulterated.
