A prescription for Amoxicillin is filled incorrectly with a different strength but labeled incorrectly. How is the product categorized?

When a prescription for Amoxicillin is filled with a different strength than what was prescribed, it raises significant concerns regarding both labeling and the quality of the product itself. If the medication is not only labeled incorrectly but is also dispensed in a strength that differs from what was authorized, it results in a product that can be categorized as both misbranded and adulterated.

The product is considered misbranded because the label does not accurately reflect the contents of the medication; it fails to provide correct information regarding the strength, which is crucial for correct patient dosing and safety. Misbranding can occur when the labeling is misleading or when it does not contain sufficient information to ensure the safe and effective use of the drug.

At the same time, the product can be categorized as adulterated if the incorrect strength leads to a dosage that does not meet the established standards for safety and effectiveness. Adulteration refers to the quality of the medication itself being compromised, which occurs when there are deviations from approved specifications. The incorrect strength compromises the integrity of the therapeutic effect expected from the drug, thereby impacting patient safety.

Thus, the proper classification of the product, in this case, is both misbranded and adulterated due to the dual issues of improper labeling and incorrect