Who Makes This Drug?
The recalled tablets were manufactured by Unichem Laboratoris Ltd., based in Goa, India, and distributed in the U.S. by Unichem Pharmaceuticals (USA), Inc. of East Brunswick, New Jersey. The company describes itself as one of the leading players in the global generic pharmaceutical industry.
The FDA’s recall was triggered by what it terms “cGMP Deviations”—meaning the manufacturer did not comply with the agency’s Current Good Manufacturing Practice regulations, which govern how pharmaceuticals must be produced to ensure quality and safety. Under U.S. law, any drug manufactured in violation of these standards is considered “adulterated,” regardless of whether it causes direct harm.
