What is the consequence if a controlled substance is found to be misbranded?

When a controlled substance is found to be misbranded, one of the key consequences is that it may be recalled. Misbranding typically signifies that the labeling or packaging of the controlled substance does not meet the regulatory standards set by the FDA or other governing agencies. This could involve false or misleading information regarding the drug, improper labeling about its contents, or lack of necessary information that ensures safe and effective use.

The recall process is vital to protect public health and ensure that consumers are not exposed to potentially harmful medications that could arise from misbranding issues. The focus here is on rectifying the situation, which may involve removing the misbranded product from the market to prevent consumer misuse or safety hazards. In this context, a recall is a direct response to a significant compliance failure that jeopardizes patients' safety.

While criminal charges, fines, and reporting to the DEA can occur in response to violations of drug regulations, the immediate and most relevant consequence of identifying a controlled substance as misbranded is the potential for a recall, making that option a direct and accurate response.