A drug manufacturer finds that bottles labeled "loratadine 10mg tablets" actually contain 5mg tablets. What is true of this product?

In this scenario, the drug in question is both adulterated and misbranded because it fails to meet the legal standards set by the FDA for labeling and product integrity.

When a product is labeled as "loratadine 10mg tablets" but contains 5mg tablets instead, it misrepresents the strength of the medication. This constitutes misbranding, as it does not have the correct information on the label, leading consumers and healthcare professionals to believe they are receiving a different dosage than what is actually in the bottle. Misbranding is defined under the Federal Food, Drug, and Cosmetic Act, particularly concerning false labeling that can mislead consumers.

Additionally, the product is considered adulterated because it differs from what it claims to be both in strength and quality. Adulteration refers to a product that fails to conform to established standards of purity or strength. In this case, the presence of 5mg tablets in a bottle labeled for 10mg tablets means that the product does not meet the requirements for identity and quality, making it potentially unsafe and ineffective.

Since the product is misbranded for not accurately representing its contents and adulterated for the discrepancy in strength, the correct conclusion is that it is both adulterated and misbranded