Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZONE GOLD because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZone 1200because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Xzen 1200 because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN PLATINUM because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN GOLD because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Black Ant because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction.
Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling AFRICAN BLACK ANT because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction.
Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs.
Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs.
Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs.
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Chemical Contamination: Product were manufactured with active pharmaceutical ingredient (API) batches contaminated with residual materials and solvents.
Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine