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U.S. Department of Health and Human Services

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Percentage of biological product recalls classified by OCBQ under Direct Recall Classification (DRC), within 45 days of receipt of additional information

Dictionary: Recalls are a firm's removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. Recalls are classified by FDA as Class I, II, or III, based on the probability that use of the recalled product will result in adverse health consequences. Class I situations represent a reasonable probability of serious adverse health consequences or death, Class II situations represent a remote probability, and Class III situations represent an unlikely probability. CBER has implemented a Direct Recall Classification (DRC) system that allows OCBQ to work directly with recalling firms in the submission of information necessary to classify the recall without expenditure of resources from FDA District Offices. This measure will allow OCBQ to monitor its performance in issuing recall classifications under DRC within timeframe goals.

Information is current as of June 30, 2014

Fiscal Year - 2013

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TimeTargetPercent
October – December 20126598
January – March 20136596
April – June 20136597
July – September 20136598

FY 2013 Total: 97%

Total number of recalls classified by OCBQ under the DRC program during the quarter that were completed within 45 days of receipt of additional information (1)

Fiscal Year - 2013
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TimeTargetNumber
October – December 2012N/A168
January – March 2013N/A148
April – June 2013N/A158
July – September 2013N/A208

FY 2013 Total: 682

Footnotes

  • (1) Beginning October 2012, this measure will be reported quarterly.

Number of recalls classified by OCBQ under the DRC program during the quarter (1)

Fiscal Year - 2013
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TimeTargetNumber
October – December 2012N/A172
January – March 2013N/A154
April – June 2013N/A163
July – September 2013N/A213

FY 2013 Total: 702

Footnotes

  • (1) Beginning October 2012, this measure will be reported quarterly.

Median number of calendar days from receipt of additional information to recall classification by OCBQ under the DRC, for recalls classified during the quarter (1)

Fiscal Year - 2013

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TimeTargetNumber
October – December 2012N/A29
January – March 2013N/A29
April – June 2013N/A27
July – September 2013N/A37

Footnotes

  • (1) Beginning October 2012, this measure will be reported quarterly.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.