Class II FDA Recall

The FDA uses three product recall classifications based on the degree of potential risk to the public: Class I, Class II, and Class III. Class I recalls involve products deemed to be dangerous enough to cause serious adverse health consequences or death.

Class II recalls occur when products might cause a temporary or medically reversible health problem. That does not mean, however, that a Class II recall won’t have devastating revenue brand or cause a significant business interruption problem.

Consider the flu vaccine recall that occurred in 2009. That Fall saw a sudden spike in demand for H1N1 and seasonal flu vaccines. Unfortunately, the vaccine dosages were not at full strength when the products were shipped. No harm would have been caused to patients, but the purported benefits of the vaccine were sorely diminished.

From a business standpoint, it is therefore perilously shortsighted for manufacturers to be anything less than fully prepared for a Class II recall. Such preparation is the key to effective food recall management, drug recall management, and medical device recall management.

No less than with Class I recalls, all food, pharmaceutical, and medical device risk managers must fully grasp complicated FDA recall compliance regulations, and, for maximum effectiveness, they must institutionalize recall procedures well ahead of need.

Bungled recalls torpedo corporate brands. Public confidence is lost even if human lives are not.

For more information, visit www.fda.gov.