Understanding and Managing Product Recalls

If you a manufacturing firm in any industry, the word “RECALL” is not one that you want to hear.  The media is currently focused General Motors and the recall involving the faulty ignition switch and why it took the company so long to publicize the issue.  These are all good questions for which GM will bear the responsibility to address.  But pharmaceutical companies have their fair share of recalls too, as can be found in the Food and Drug Administration’s (FDA) weekly Enforcement Report.

The Code of Federal Regulations, Title 21, Part 7 (Enforcement Policy) defines the recall procedure and includes when and how a recall should be initiated.  The policy is further described in a guidance document, initially published in 2003.  Yet, some companies are not aware of their obligations and/or downplay problems that arise, believing they do not rise to the level necessitating a recall.

So why are companies reluctant to initiate a recall?  Certainly it is going to cost both money and time; there are the actual recall expenditures, lost income from not having product on the market, investigations into what went wrong and implementing the necessary corrective action.  There is fear of bad publicity and/or potential lawsuits, especially if there is a significant health hazard presented.  In addition, a recall may prompt an FDA inspection, which could result in the agency identifying further deficiencies in your systems and procedures.

These are all very real concerns faced by manufacturing firms but it does not mean that recalls should be avoided.  If one of your products on the market has deteriorated or is not meeting its specification, it is best to act quickly to address the problem.  Identify and isolate the offending product, contact the FDA and make them aware of the situation, investigate the problem and initiate corrective action, prepare your recall communications and contact your customers.  Use the recall as a basis for identifying those systems and procedures that were deficient and take the opportunity to improve them.

If the problem is ignored, the long term consequences could be far greater – lost sales, unhappy customers not to mention possible litigation and the bad publicity that may ensue.  But if the FDA, your customers and the public see that your company is taking safety and regulatory compliance seriously, you will survive a recall and learn from it.