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U.S. Department of Health and Human Services

About FDA

Number of Class I recalls classified

Dictionary: Using the recall process, manufacturers may voluntarily remove a drug from the marketplace if a drug quality defect is found. 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.

Information is current as of December 31, 2013.

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/AN/A
Nov 2011N/AN/A
Dec 2011N/AN/A
Jan 2012N/AN/A
Feb 2012N/AN/A
Mar 2012N/AN/A
Apr 2012N/AN/A
May 2012N/AN/A
Jun 2012N/AN/A
Jul 2012N/A2
Aug 2012N/A2
Sep 2012N/A2

FY 2012 3 month Total: 6

Footnotes

  • CDER created new measures and began collecting data in July 2012. Therefore, FY12 will only include 3 months of data.

Number products impacted by Class I recalls

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/AN/A
Nov 2011N/AN/A
Dec 2011N/AN/A
Jan 2012N/AN/A
Feb 2012N/AN/A
Mar 2012N/AN/A
Apr 2012N/AN/A
May 2012N/AN/A
Jun 2012N/AN/A
Jul 2012N/A2
Aug 2012N/A2
Sep 2012N/A4

FY 2012 3 month Total: 8

Number of Class II recalls classified

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/AN/A
Nov 2011N/AN/A
Dec 2011N/AN/A
Jan 2012N/AN/A
Feb 2012N/AN/A
Mar 2012N/AN/A
Apr 2012N/AN/A
May 2012N/AN/A
Jun 2012N/AN/A
Jul 2012N/A14
Aug 2012N/A21
Sep 2012N/A12

FY 2012 3 month Total: 47

Number products impacted by Class II recalls

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/AN/A
Nov 2011N/AN/A
Dec 2011N/AN/A
Jan 2012N/AN/A
Feb 2012N/AN/A
Mar 2012N/AN/A
Apr 2012N/AN/A
May 2012N/AN/A
Jun 2012N/AN/A
Jul 2012N/A17
Aug 2012N/A23
Sep 2012N/A22

FY 2012 3 month Total: 62

Number of Class III recalls classified

Fiscal Year - 2012

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TimeTargetNumber
Oct 2011N/AN/A
Nov 2011N/AN/A
Dec 2011N/AN/A
Jan 2012N/AN/A
Feb 2012N/AN/A
Mar 2012N/AN/A
Apr 2012N/AN/A
May 2012N/AN/A
Jun 2012N/AN/A
Jul 2012N/A11
Aug 2012N/A11
Sep 2012N/A4

FY 2012 3 month Total: 26

Number products impacted by Class III recalls

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/AN/A
Nov 2011N/AN/A
Dec 2011N/AN/A
Jan 2012N/AN/A
Feb 2012N/AN/A
Mar 2012N/AN/A
Apr 2012N/AN/A
May 2012N/AN/A
Jun 2012N/AN/A
Jul 2012N/A13
Aug 2012N/A12
Sep 2012N/A5

FY 2012 3 month Total: 30

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.