Regulatory Focus™ > News Articles > Update to FDA's Regulatory Procedures Manual Clarifies Definition of Recall

Update to FDA's Regulatory Procedures Manual Clarifies Definition of Recall

Posted 28 October 2013 | By Alexander Gaffney, RAC

At what point does a recall of products regulated by the US Food and Drug Administration (FDA) cease to become a recall? It's a question with major implications for the industry, and now a revised FDA document is casting new light on the topic.


Recall regulations stipulate that any action taken by a manufacturer to correct a defect or performance failure that could pose a risk to public health may be defined as the agency as a recall, even if the action is conducted voluntarily, as it often is.

In those cases, manufacturers are required by FDA to submit various information (depending on the type of product involved), including the product name, model, approval or clearance number, lot/unit number, and a reason for the recall. The latter should, according to FDA's Guidance for Industry: Product Recalls, Including Removals and Corrections, include a detailed explanation of how the product is either defective or violative, how it affects the safety of the product, the nature of the defect and any information on how users should protect themselves in the meantime.

However, FDA also makes a range of distinctions when defining a recall as such. For example, if a product is recalled for reasons related to safety, efficacy or the conditions under which it was manufactured (i.e. current good manufacturing practices, or CGMPs), then that activity will be classified as a recall.

Conversely, if a company initiates a recall of goods for economic reasons, such as replacing an older model medical device with a new one, then that action is not considered a recall, but rather a "product enhancement" or "stock recall." Neither would be given a recall classification by FDA.

RPM Update

FDA has published guidance in the past to clarify which conditions would cause a product withdrawal to be classified as a recall, but its February 2013 guidance only applies to medical devices, which are more likely to be withdrawn for product enhancements due to their iterative design process.

Now, though, FDA has published an updated version of its Regulatory Procedures Manual (RPM), its reference manual for FDA staff members, reflecting updated definitions of several recall-related terms.

In a 23 October 2013 notice, FDA explains that the newly revised document now reflects a new definition for the term "market withdrawal."

For example, the term now allows a company to withdraw a product that has allegedly been tampered with (individual units only) without it being classified as a traditional recall. "Although the situation may present a health hazard, there is no one identified as responsible for the violation," FDA explained. "This will allow documentation and monitoring of the market withdrawal."

The RPM update calls to mind an infamous incident in the 1980s involving Tylenol units manufactured by Johnson & Johnson which had been tampered with, resulting in the deaths of several people by cyanide. Under the current definition, FDA would recommend that such a recall be classified as a market withdrawal and not a formal recall (though it would likely accompany significant warnings elsewhere in its communications with the public).

The section also clarifies that products distributed by foreign firms in the US are subject to the same processing, classification, and publication standards as US-based companies.

FDA RPM Update

RPM Section on Recall Classifications

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