Next Upcoming Seminar: Dairy Processing 101 Seminar – June 13-15, 2017

Specializing in FDA Regulatory Matters

OTC 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 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 Consulting Group, LLC can assist with recall prevention strategies through audits of Good Manufacturing Practices (GMPs), review of labeling and claims on packaging and marketing materials, as well ingredient and toxicology reviews and appropriate filings and documentation. EAS can also 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.