Drug Recalls

A product recall is a time-consuming and expensive endeavor but is required whenever a regulated product is found to be either defective or potentially harmful. While drug recalls are generally caused by a failure of a product to meet FDA regulations, the FTC may request a recall if label or website claims do not meet appropriate levels of substantiation, or the CPSC may determine that a product’s packaging is not in compliance. Whether the recall is voluntary or requested by these agencies, the recalling firm must have a procedure in place to ensure all violative product is removed from the marketplace.

From ingredient/component suppliers to manufacturing /processing/labeling, to the distribution of the products within the U.S. market, firms should take a proactive approach to ensure the safety of their product and reduce the potential for a recall. EAS can assist with the performance of a mock recall to assess your readiness to execute an actual recall.

In the unfortunate event of a recall, EAS consultants can advise on the recall process to ensure compliance and act as a conduit of information between your company and the FDA. or other government agency.