For which reason can a drug product consisting of tablets be declared adulterated?

The correct reason a drug product consisting of tablets can be declared adulterated is if it contains harmful substances. Adulteration refers to the presence of unapproved or harmful ingredients in a product that can compromise its safety, efficacy, or quality. In the context of pharmaceutical products, if a drug contains substances that are toxic or potentially harmful to patients, it clearly fails to meet the established safety standards.

Declaring a product adulterated based on harmful substances is grounded in regulatory guidelines that ensure the safety of medications. The FDA and other regulatory agencies have strict criteria that define what constitutes harmful substances, and any product that falls under this definition poses a significant risk to consumers.

While information about the number of tablets present, compliance with manufacturing standards, and expiration status are important for labeling and quality assurance, they do not directly address the inherent safety of the product itself regarding harmful ingredients. Therefore, products must be free from any substances that could endanger health to be considered safe and not adulterated.