• Decrease
  • Normal
  • Increase
U.S. Department of Health and Human Services

About FDA

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, 2014

Fiscal Year - 2012

Skip graphic and jump to text data

TimeTargetPercent
Oct 20116598
Nov 201165100
Dec 201165100
Jan 201265100
Feb 201265100
Mar 20126597
Apr 201265100
May 201265100
Jun 201265100
Jul 20126598
Aug 20126596
Sep 201265100

FY 2012 Overall: 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 - 2012
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2011N/A57
Nov 2011N/A50
Dec 2011N/A55
Jan 2012N/A51
Feb 2012N/A51
Mar 2012N/A28
Apr 2012N/A65
May 2012N/A57
Jun 2012N/A155
Jul 2012N/A126
Aug 2012N/A51
Sep 2012N/A55

FY 2012 Total: 801

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 - 2012
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2011N/A58
Nov 2011N/A50
Dec 2011N/A55
Jan 2012N/A51
Feb 2012N/A51
Mar 2012N/A29
Apr 2012N/A65
May 2012N/A57
Jun 2012N/A155
Jul 2012N/A128
Aug 2012N/A53
Sep 2012N/A55

FY 2012 Total: 807

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 - 2012

Skip graphic and jump to text data

TimeTargetNumber
Oct 2011N/A32
Nov 2011N/A20
Dec 2011N/A21
Jan 2012N/A27
Feb 2012N/A15
Mar 2012N/A18
Apr 2012N/A22
May 2012N/A20
Jun 2012N/A18
Jul 2012N/A26
Aug 2012N/A23
Sep 2012N/A30

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.