Regulatory Focus™ > News Articles > FDA Looking to Speed up Public Notification of Recalls

FDA Looking to Speed up Public Notification of Recalls

Posted 01 June 2012 | By Alexander Gaffney, RAC 

An item tucked within the US Food and Drug Administration's (FDA) weekly enforcement report indicates the agency is looking to speed up the way it notifies the general public regarding pharmaceutical recalls.

FDA current publishes its recalls of all products in an extensive and sprawling document known as its Enforcement Report, which it publishes every Wednesday. The Enforcement Report is organized by product type and by the severity of the recall, but it is difficult to find information in the report and does not contain any information to help consumers decipher the seriousness of each recall. The document is also prone to lags in information, as it can take time to classify a recall by order of its importance and risk to the public.

To mitigate some of those concerns, FDA said it "will modify the drug product section of the Enforcement Report […] to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action."

Class I recalls are rated as being the most serious recalls, while Class II and III recalls refer to sequentially less serious issues necessitating a recall of the affected product or products. Under the new pilot, drug products which have not been given a recall classification will be posted under a section entitled, "Recalls Pending Classification: DRUGS," and later reposted with their appropriate classification once it has been established by FDA.

The agency is calling for feedback on its enforcement report, including suggestions, which it is soliciting through an email address (

Read more:

FDA - Enforcement Report for May 30, 2012

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