FDA (Drugs) recall action 76644
The FDA (Drugs) publishes a recall like this one as 21 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 21 pages.
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate, an inactive ingredient in several modified release solid oral dosage forms, making this product unapproved drug for which safety and efficacy have not been establish and therefore, subject to recall.
The agency’s own wording, quoted from the enforcement report.
A&H Focal Inc. is recalling Clalis capsules because they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.
A&H Focal Inc. is recalling Miraculous Evil Root capsules because FDA analysis found they contain sildenafil, an unapproved drug with unestablished safety and efficacy.
A&H Focal Inc. is recalling Gold Vigra capsules because they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.
A&H Focal Inc. is recalling Power V8 Viagra tablets because they contain sildenafil, an unapproved drug with unestablished safety and efficacy.
A&H Focal Inc. is recalling LANG YI HAO CHAONONGSUOPIAN tablets because they contain sildenafil without FDA approval. The products were sold in New York and New Jersey.
A&H Focal Inc. is recalling HU HU SHENG WEI capsules because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.
A&H Focal Inc. is recalling MACA gold tablets sold in New York and New Jersey because they contain sildenafil, an unapproved drug.
A&H Focal Inc. is recalling Zhonghua Niubian tablets found to contain sildenafil, an unapproved drug for erectile dysfunction.
A&H Focal Inc. is recalling Germany Niubian tablets because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.
A&H Focal Inc. is recalling Black Ant capsules found to contain sildenafil, an unapproved drug with unestablished safety and efficacy.
A&H Focal Inc. is recalling Tiger King tablets because they contain sildenafil, an unapproved drug for erectile dysfunction, and lack FDA approval.
A&H Focal Inc. is recalling Yanshijiaonang capsules because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.
A&H Focal Inc. is recalling DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets because they contain sildenafil, an unapproved drug for erectile dysfunction.
A&H Focal Inc. is recalling Indian God Lotion Spray Bottles because the product is an unapproved drug containing diethyl phthalate.
The FDA is recalling ZHANSHENG WEIGE CHAOYUE XILISHI tablets because they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.
A&H Focal Inc. is recalling MAX MAN capsules sold in New York and New Jersey because they contain sildenafil, an unapproved drug with unestablished safety and efficacy.
A&H Focal Inc. is recalling Ye Lang Shen capsules because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.
A&H Focal Inc. is recalling Germany Black Gold tablets because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.
A&H Focal Inc. is recalling LIEN CHAN FOR SEVEN DAYS capsules because they contain sildenafil, an unapproved drug with unestablished safety and efficacy.
A&H Focal Inc. is recalling Hard Ten Days capsules because they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.
A&H Focal Inc. is recalling STREE OVERLORD capsules because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.