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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 September 30, 2021

Fiscal Year - 2021

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TimeTargetPercent
Oct - Dec 2020N/A98
Jan - Mar 2021N/A99
Apr - Jun 2021N/A100
Jul - Sept 2021N/A100

FY 2021 Total: 99%

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 - 2021
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TimeTargetNumber
Oct - Dec 2020N/A108
Jan - Mar 2021N/A143
Apr - Jun 2021N/A96
Jul - Sept 2021N/A111

FY 2021 Total: 458

Footnotes

  • (1) This measure was tracked monthly from January 2010 through September 2012, and tracked quarterly from October 2012 through present.

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

Fiscal Year - 2021
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TimeTargetNumber
Oct - Dec 2020N/A110
Jan - Mar 2021N/A145
Apr - Jun 2021N/A96
Jul - Sept 2021N/A111

FY 2021 Total: 462

Footnotes

  • (1) This measure was tracked monthly from January 2010 through September 2012, and tracked quarterly from October 2012 through present.

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 - 2021
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TimeTargetNumber
Oct - Dec 2020N/A10
Jan - Mar 2021N/A15
Apr - Jun 2021N/A19
Jul - Sept 2021N/A19

FY 2021 Total: 63

Footnotes

  • (1) This measure was tracked monthly from January 2010 through September 2012, and tracked quarterly from October 2012 through present.

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.

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