Having a product that is regulated by the Food and Drug Administration (FDA) recalled can have devastating consequences. When the situation is not managed properly, in addition to harming the public, it can result in liability and injury to the company and brand. These problems can be needlessly magnified by a failure to timely and efficiently respond to defective products in the marketplace. Therefore, companies that manufacture or distribute products regulated by the FDA must put strategies and procedures in place to safely and effectively manage a product recall.
The proper management of a recall is top priority for protecting the public's health. Identifying and recalling the specifically affected products is often the most effective means for protecting consumers. If the cause of the defect is located promptly, the recall can be contained to only those products warranting such action. This prevents needless alarm among unaffected members of the public. In order to plan and execute a proper recall, companies should know the basics of a product recall (ABC's), and thereby avoid both unnecessary harm to consumers and costly missteps that can result in needless liability and costs.
A) Alert regulatory agencies promptly.
The FDA must be notified as soon as possible, so the first step in any recall is to accurately identify and quantify the product being recalled. Understanding the origin of the defect in a product can contain the scope of the recall to those lots or expiration dates having the potential for problems. Having a proper quality control system using sufficient coding of regulated products makes it possible to positively identify, contain the scope of and facilitate effective recall of all faulty lots. Companies should prepare and maintain a current written contingency plan for use in initiating proper interactions with the FDA.
The FDA needs to know:
- An estimate of the amount of recalled product in the marketplace.
- The lots affected by the recall.
- Information regarding the distribution pattern of the product.
- The reason for the recall.
- The nature of the defect.
Finally, the recalling firm is required to provide an assessment of the health risk associated with the deficiency and an outline of the recall strategy.
B) Be transparent with the public.
Alerting the public to a product recall should be the highest priority and done promptly. In a situation where the product may pose a significant health hazard and is in the hands of consumers, a press release approved by the FDA is required. Particular consideration should be taken regarding potential future liability. In addition, all customers in the distribution chain should be notified of the recall in writing that provides the necessary actions needed to effectively remove the product from sale, or procedures for product correction or destruction. A quality control system should also include product distribution records so that it is easy to locate the products being recalled.
C) Check the effectiveness of the recall.
It is the recalling firm's responsibility to assure that the recall is effective. Effectiveness checks should be conducted to verify that notification letters were received, read and understood and that instructions were followed accurately. An effectiveness check should also verify that a recall reached the appropriate level in the distribution chain. Any proper contingency plan should include contact information for outside regulatory professionals that can help the company navigate the regulatory and legal considerations of a product recall. A recall is considered complete after all of the company's corrective actions are reviewed by the FDA and deemed appropriate.
In addition to potentially being harmful to consumers, a recall can also be disruptive to a company's operation and business. With prior planning, prudent businesses can minimize many of these risks. In case of a product defect, remember your ABC's: Alert regulatory agencies promptly, Be transparent with the public, and Check the effectiveness of the recall
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