Several of my colleagues and I had an interesting conversation the other day about product recalls. As we traced through the FDA requirements for product recalls, we realized that many practitioners may be unaware of their role in the recall process. As a result, many may not have practices in place to efficiently fulfill recall obligations. In the absence of these business practices, patients’ safety could be jeopardized.
Dietary supplement recalls typically result from the discovery of an “out of specification” finding in a product that has already been released into commerce. There are two ways recalls may be generated. They may originate from consumer complaints, which, after evaluation, the FDA forwards to the manufacturer. Recalls may also result from a manufacturer’s own discovery through post-release testing or from customer complaints reported directly to them. In either case, the most common reasons for recalls are undeclared allergens, mislabeling, the presence of contaminants, questionable stability, and incorrect potency. When any of these issues are found, the federal guidelines of 21CFR part 111 require the company listed on the product label to remove the risk of harm from use of the product. This typically means issuing a product recall. In the case of companies that utilize contract manufacturers, it is still the company whose name appears on the product label that bears responsibility to complete a product recall. If the issue originated with a contract manufacturer, the manufacturer would notify any company for which it manufactures, and it would then be the responsibility of the final product company to initiate a customer recall.
How Recalls Work
Drug and dietary supplement recalls are classified as class I, II, or III. Class I recalls carry the risk of serious harm or death to the end-user. Class I recalls are often mandated by the FDA and are fairly rare. For instance, if a raw material were found to be contaminated with a serious pathogen, all products containing the affected lot of pathogen-contaminated raw material would be under a class I recall. Class II recalls include those products that may cause temporary and reversible adverse effects in the end-user. A class III recall is used for products that may cause adverse non-serious effects. As a whole, all recalls are serious and serve the important function of protecting the end-user.
The most common reasons for recalls are undeclared allergens, mislabeling, the presence of contaminants, questionable stability, and incorrect potency.
When a product is recalled, the brand company must send timely notice to all the customers who purchased affected products. In some cases, it is one lot of a finished product. If the issue originated with a raw material that went into several products, multiple finished products will be recalled. This is why one of the most important aspects of quality control is the tracking system in place for all raw materials and finished product by lot number. At any point in time, the brand company should be able to determine the lot number of every component in their finished products, including the gelatin capsules; the bottle containing the product; the active ingredients; and any fillers, binders, or excipients. This tracking system must be verified and part of the controlled document system of the company so that the accuracy is maintained at all times. With this system in place, a company is able to accurately determine which products need to be recalled.
A recall notice is sent to all customers with the affected product lots noted. Typically, the recall notice asks the customer to return the product to the brand company (at the company’s expense), but in some cases the customer may be asked to dispose of the product. The recall notices must include the reason for the recall, which helps the end-users determine whether their health might have been put at risk from their use of the product. In the situation in which a brand company is selling directly to the end-user, a recall is fairly straightforward. However, in most cases there are distributors and/or retail outlets that create more complexity to the recall.
Recalls of Products Sold Through Distributors
Distributors represent an additional layer through which the recall information must travel to get to the end-product user. Distributors maintain customer lists, which may be retail outlets or individuals. The distributor communicates recall notices to these customers, who in turn must then issue a recall to their customers on behalf of the brand company. Again, when the customer is the end-user, then the process is fairly straightforward and the customer is notified directly. However, in the case of retail outlets, such as clinics, pharmacies, or retail stores, the recall notice will go to the establishment. It is then imperative that the retail outlet notify all of its patients/customers who bought the affected product.
The Importance of Good Recordkeeping
If detailed records are kept and lot numbers known, then in the event of a recall, the patients/customers who purchased the affected products can be easily identified. But if sellers do not keep a record of lot numbers of products dispensed, in the event of a recall, they would have no other choice but to notify all patients who bought that product at any time since the affected lot was introduced into commerce. If sellers do not keep a record of who purchases which products, then in the event of a recall they would need to notify everyone who bought any product within the affected time frame of the recall. This is both inefficient and possibly harmful to the seller’s reputation. Good tracking systems and reliable suppliers are important safeguards for the health of the patients, as well as for the viability of the seller’s business.
