Prescription Drugs

Lack of Processing Controls

Lack of Processing Controls

Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared fluoxetine, an FDA approved drug used to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.

Lack of Processing Controls

Lack of Processing Controls

Lack of Processing Controls

Lack of Processing Controls

Lack of Processing Controls

Lack of Processing Controls

Lack of Processing Controls

Lack of Processing Controls

Lack of Processing Controls

Failed impurities/degradation: out of specification result for impurity secorapamycin.

Lack of Processing Controls

Lack of Processing Controls

Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.

Subpotent Drug

Lack of Processing Controls

Lack of Processing Controls

Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.