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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 March 31, 2014

Fiscal Year - 2014

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TimeTargetPercent
October – December 20136591
January – March 20146597
April – June 201465TBD
July – September 201465TBD

FY 2014 YTD: 94%

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 - 2014
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TimeTargetNumber
October – December 2013N/A146
January – March 2014N/A116
April – June 2014N/ATBD
July – September 2014N/ATBD

FY 2014 YTD: 262

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 - 2014
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TimeTargetNumber
October – December 2013N/A160
January – March 2014N/A119
April – June 2014N/ATBD
July – September 2014N/ATBD

FY 2014 YTD: 279

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 - 2014

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TimeTargetNumber
October – December 2013N/A36
January – March 2014N/A32
April – June 2014N/ATBD
July – September 2014N/ATBD

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.