Class I · High risk
Actra-SX 500 Capsules
Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction
3 recalls, newest first
Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction
Chemical Contamination: QS Plus wipes were found to be contaminated with different substance (7820, Graffiti Remover).
Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA).