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U.S. Department of Health and Human Services

About FDA

Total number of recall events in the month for which the classification process was completed

Dictionary: Using the recall process, manufacturers may voluntarily remove a drug from the marketplace if a drug quality defect is found. The Office of Compliance (OC) classifies the recall (or recommends classification in some cases) based on the level of public health risk. A Class I recall is the most significant recall. A recall may be done for a single product dosage form or for multiple dosage forms, or multiple products, therefore we report both the number of recall events and the number of products recalled.


These measures have been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.

Fiscal Year - 2011

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TimeTargetNumber
Oct 2010N/A15
Nov 2010N/A23
Dec 2010N/A34
Jan 2011N/A19
Feb 2011N/A31
Mar 2011N/A47
Apr 2011N/A35
May 2011N/A16
Jun 2011N/A47
Jul 2011N/A41
Aug 2011N/A71
Sep 2011N/A40

Number of Class I recalls classified by Office of Regulatory Affairs (ORA) after recommendation by CDER Compliance (1)

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A3
Nov 2010N/A2
Dec 2010N/A4
Jan 2011N/A4
Feb 2011N/A3
Mar 2011N/A2
Apr 2011N/A7
May 2011N/A2
Jun 2011N/A4
Jul 2011N/A0
Aug 2011N/A8
Sep 2011N/A4

Footnotes

  • (1) Authority to designate a drug recall as Class I currently rests with the Associate Commissioner for Regulatory Affairs (ACRA)

Percent Class 1 recall events from tainted supplements

Performance measure implemented FY 2011

Fiscal Year - 2011
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Performance measure implemented FY 2011

TimeTargetPercent
Oct 2010N/A67
Nov 2010N/A0
Dec 2010N/A75
Jan 2011N/A100
Feb 2011N/A33
Mar 2011N/A100
Apr 2011N/A57
May 2011N/A100
Jun 2011N/ATBA
Jul 2011N/A0
Aug 2011N/A63
Sep 2011N/A50

Number of products impacted by Class I recalls

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A4
Nov 2010N/A2
Dec 2010N/A6
Jan 2011N/A29
Feb 2011N/A3
Mar 2011N/A2
Apr 2011N/A8
May 2011N/A2
Jun 2011N/A5
Jul 2011N/A0
Aug 2011N/A25
Sep 2011N/A5

Percent of products impacted that are tainted supplements

Performance measure implemented FY 2011

Fiscal Year - 2011
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Performance measure implemented FY 2011

TimeTargetPercent
Oct 2010N/A75
Nov 2010N/A0
Dec 2010N/A67
Jan 2011N/A100
Feb 2011N/A33
Mar 2011N/A100
Apr 2011N/A63
May 2011N/A100
Jun 2011N/A60
Jul 2011N/A0
Aug 2011N/ATBD
Sep 2011N/ATBD

Number of Class II recalls classified

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A9
Nov 2010N/A17
Dec 2010N/A15
Jan 2011N/A10
Feb 2011N/A19
Mar 2011N/A28
Apr 2011N/A20
May 2011N/A7
Jun 2011N/A23
Jul 2011N/A29
Aug 2011N/A41
Sep 2011N/A27

Number of products impacted by Class II recalls

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A18
Nov 2010N/A65
Dec 2010N/A43
Jan 2011N/A16
Feb 2011N/A44
Mar 2011N/A95
Apr 2011N/A22
May 2011N/A59
Jun 2011N/A42
Jul 2011N/A121
Aug 2011N/A93
Sep 2011N/A693

Number of Class III recalls classified

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A3
Nov 2010N/A4
Dec 2010N/A15
Jan 2011N/A5
Feb 2011N/A9
Mar 2011N/A17
Apr 2011N/A8
May 2011N/A7
Jun 2011N/A20
Jul 2011N/A12
Aug 2011N/A22
Sep 2011N/A9

Number of products impacted by Class III recalls

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A3
Nov 2010N/A7
Dec 2010N/A19
Jan 2011N/A14
Feb 2011N/A25
Mar 2011N/A33
Apr 2011N/A12
May 2011N/A12
Jun 2011N/A35
Jul 2011N/A13
Aug 2011N/A31
Sep 2011N/A42

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.