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U.S. Department of Health and Human Services

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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 - 2010

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TimeTargetNumber
Oct 2009N/A20
Nov 2009N/A23
Dec 2009N/A5
Jan 2010N/A9
Feb 2010N/A8
Mar 2010N/A37
Apr 2010N/A24
May 2010N/A16
Jun 2010N/A32
Jul 2010N/A20
Aug 2010N/A26
Sep 2010N/A38

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

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A0
Nov 2009N/A2
Dec 2009N/A1
Jan 2010N/A0
Feb 2010N/A1
Mar 2010N/A3
Apr 2010N/A3
May 2010N/A3
Jun 2010N/A4
Jul 2010N/A2
Aug 2010N/A2
Sep 2010N/A8

Footnotes

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

Number of products impacted by Class I recalls

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A0
Nov 2009N/A2
Dec 2009N/A1
Jan 2010N/A0
Feb 2010N/A1
Mar 2010N/A7
Apr 2010N/A8
May 2010N/A12
Jun 2010N/A66
Jul 2010N/A2
Aug 2010N/A30
Sep 2010N/A29

Number of Class II recalls classified

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A12
Nov 2009N/A9
Dec 2009N/A2
Jan 2010N/A2
Feb 2010N/A3
Mar 2010N/A19
Apr 2010N/A17
May 2010N/A8
Jun 2010N/A17
Jul 2010N/A11
Aug 2010N/A19
Sep 2010N/A19

Number of products impacted by Class II recalls

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A21
Nov 2009N/A88
Dec 2009N/A2
Jan 2010N/A2
Feb 2010N/A3
Mar 2010N/A25
Apr 2010N/A30
May 2010N/A21
Jun 2010N/A42
Jul 2010N/A17
Aug 2010N/A48
Sep 2010N/A90

Number of Class III recalls classified

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A8
Nov 2009N/A12
Dec 2009N/A2
Jan 2010N/A7
Feb 2010N/A4
Mar 2010N/A15
Apr 2010N/A4
May 2010N/A5
Jun 2010N/A11
Jul 2010N/A7
Aug 2010N/A5
Sep 2010N/A11

Number of products impacted by Class III recalls

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A8
Nov 2009N/A14
Dec 2009N/A2
Jan 2010N/A187
Feb 2010N/A6
Mar 2010N/A27
Apr 2010N/A5
May 2010N/A14
Jun 2010N/A20
Jul 2010N/A10
Aug 2010N/A7
Sep 2010N/A21

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.