NORCROSS, Ga.—Hi-Tech Pharmaceuticals is recalling all lots of its Stamina-Rx product, six weeks after the company was informed by FDA that lab tests showed the presence of undeclared benzamidenafil, a pharmaceutical used for treating erectile dysfunction. The products were marketed as dietary supplements, although the presence of a drug makes them adulterated products; further, in its May 1 letter to Hi-Tech, FDA added the marketing of the products online and in product labeling positioned the products as unapproved new drugs, not dietary supplements.
Hi-Tech has been under a Consent Decree of Permanent Injunction with FDA since late 2003, after the agency found Stamina-Rx products made by Hi-Tech’s partner NVE Inc. contained undeclared tadalafil, another drug for treating erectile dysfunction.