A&H Focal Inc., has issued a nationwide recall of 29 products marketed as dietary supplements marketed for sexual enhancement and erectile dysfunction because numerous laboratory tests conducted by the Food and Drug Administration (FDA) in recent years have found the products contain hidden drug ingredients that may cause serious health problems for some people.
Laboratory analyses found traces of PDE-5 inhibitors in several A&H Focal’s dietary supplements. PDE-5 inhibitors are a class of drugs that include the active ingredient in the prescription erectile dysfunction drugs Viagra and Cialis. This renders the dietary supplements unapproved drugs under the Federal Food, Drug and Cosmetic Act.
This undeclared active ingredient poses a risk to consumers because they can interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Affected products were sold by A&H Focal since January 2014 to present. They were primarily sold through Asian Markets in New Jersey and New York. Consumers who have any of these products should immediately stop use and discard them.
Anyone who has taken these products and suffered adverse effects should file a report with the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Affected products include the following:
Black Ant (4600 mg)
Indian God Lotion
Evil Root (1200 mg)
Germany Black Gold (2800 mg)
Germany Niubian (3000 mg)
Hard Ten Days (4500 mg)
Lang Yi Hao (Chaonogsuopian) (500 mg)
Ye Lang Shen (5000 mg)
Zhansheng Weige Chaoyue Xillshi (2000 mg)
Zhonghua Nilubian (2000 mg)
Stree Overlord (3800 mg)
Max Man (3000 mg)
Hu Hu Sheng Wei
Viagra 100 (2000 mg)
Power V8 Viagra (200 mg)
LeinChan for Seven Days
Maca Gold (6800 mg)