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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 - 2011

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TimeTargetPercent
Oct 20106578
Nov 201065100
Dec 20106598
Jan 20116588
Feb 201165100
Mar 20116597
Apr 20116596
May 20116599
Jun 201165100
Jul 20116598
Aug 201165100
Sep 20116598

FY 2011 Overall: 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 - 2011
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TimeTargetNumber
Oct 2010N/A50
Nov 2010N/A84
Dec 2010N/A55
Jan 2011N/A28
Feb 2011N/A57
Mar 2011N/A62
Apr 2011N/A50
May 2011N/A75
Jun 2011N/A71
Jul 2011N/A67
Aug 2011N/A100
Sep 2011N/A63

FY 2011 Total: 762

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 - 2011
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TimeTargetNumber
Oct 2010N/A64
Nov 2010N/A84
Dec 2010N/A56
Jan 2011N/A32
Feb 2011N/A57
Mar 2011N/A64
Apr 2011N/A52
May 2011N/A76
Jun 2011N/A71
Jul 2011N/A68
Aug 2011N/A100
Sep 2011N/A64

FY 2011 Total: 788

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 - 2011

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TimeTargetNumber
Oct 2010N/A35
Nov 2010N/A20
Dec 2010N/A19
Jan 2011N/A21
Feb 2011N/A20
Mar 2011N/A14
Apr 2011N/A13
May 2011N/A14
Jun 2011N/A15
Jul 2011N/A18
Aug 2011N/A19
Sep 2011N/A23

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.