South Amboy, NJ couple admits selling misbranded, unapproved drugs
A married couple from Middlesex County marketed and distributed over $3 million worth of misbranded and unapproved drugs, according to guilty pleas announced Wednesday by U.S. Attorney Phillip Sellinger.
South Amboy residents Sylvia Kovaleski, 43, and Keith Kovaleski, 57, pleaded guilty this week and could spend up to five years in prison and pay a hefty fine.
As the operators of All American Peptide, officials said, the Kovaleskis sold prescription drugs, such as tadalafil, the active ingredient in Cialis, and peptides and SARMS, which are used as an alternative to steroids. In addition, the couple sold drugs that had not been approved for human use, such as clenbuterol, a drug sold in foreign markets.
Using their basement as a manufacturing facility, and mislabeling products as their own, the couple made capsules containing "significantly higher doses" of tadalafil than the highest recommended dosage, officials said. Also, the couple failed to provide adequate directions for their products, such as dosage information and warnings about the side effects.
As part of their plea deal, the Kovaleskis must forfeit more than $3 million in criminal proceeds. Sentencing is scheduled for July 26.