Main 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. <i>Information is current as of March 31, 2013</i> Percent 0 100

FY 2011 Overall: 97%

Oct 2010 65 78 Nov 2010 65 100 Dec 2010 65 98 Jan 2011 65 88 Feb 2011 65 100 Mar 2011 65 97 Apr 2011 65 96 May 2011 65 99 Jun 2011 65 100 Jul 2011 65 98 Aug 2011 65 100 Sep 2011 65 98 0 100

FY 2012 Overall: 99%

Oct 2011 65 98 Nov 2011 65 100 Dec 2011 65 100 Jan 2012 65 100 Feb 2012 65 100 Mar 2012 65 97 Apr 2012 65 100 May 2012 65 100 Jun 2012 65 100 Jul 2012 65 98 Aug 2012 65 96 Sep 2012 65 100 0 100

FY 2013 YTD: 97%

October – December 2012 65 98 January – March 2013 65 96 April – June 2013 65 July – September 2013 65 Sub Percentage of biological product recalls classified by OCBQ under Direct Recall Classification (DRC), within 45 days of receipt of additional information (1) Beginning October 2012, this measure will be reported quarterly. Number column

FY 2011 Total: 762

Oct 2010 50 Nov 2010 84 Dec 2010 55 Jan 2011 28 Feb 2011 57 Mar 2011 62 Apr 2011 50 May 2011 75 Jun 2011 71 Jul 2011 67 Aug 2011 100 Sep 2011 63

FY 2012 Total: 801

Oct 2011 57 Nov 2011 50 Dec 2011 55 Jan 2012 51 Feb 2012 51 Mar 2012 28 Apr 2012 65 May 2012 57 Jun 2012 155 Jul 2012 126 Aug 2012 51 Sep 2012 55 0

FY 2013 YTD: 316

October – December 2012 168 January – March 2013 148 April – June 2013 July – September 2013 Sub Percentage of biological product recalls classified by OCBQ under Direct Recall Classification (DRC), within 45 days of receipt of additional information (1) Beginning October 2012, this measure will be reported quarterly. Number column

FY 2011 Total: 788

Oct 2010 64 Nov 2010 84 Dec 2010 56 Jan 2011 32 Feb 2011 57 Mar 2011 64 Apr 2011 52 May 2011 76 Jun 2011 71 Jul 2011 68 Aug 2011 100 Sep 2011 64

FY 2012 Total: 807

Oct 2011 58 Nov 2011 50 Dec 2011 55 Jan 2012 51 Feb 2012 51 Mar 2012 29 Apr 2012 65 May 2012 57 Jun 2012 155 Jul 2012 128 Aug 2012 53 Sep 2012 55 0

FY 2013 YTD: 326

October – December 2012 172 January – March 2013 154 April – June 2013 July – September 2013 Main (1) Beginning October 2012, this measure will be reported quarterly. Number column

Oct 2010 35 Nov 2010 20 Dec 2010 19 Jan 2011 21 Feb 2011 20 Mar 2011 14 Apr 2011 13 May 2011 14 Jun 2011 15 Jul 2011 18 Aug 2011 19 Sep 2011 23

Oct 2011 32 Nov 2011 20 Dec 2011 21 Jan 2012 27 Feb 2012 15 Mar 2012 18 Apr 2012 22 May 2012 20 Jun 2012 18 Jul 2012 26 Aug 2012 23 Sep 2012 30 0

October – December 2012 29 January – March 2013 29 April – June 2013 July – September 2013 http://www.fda.gov/AboutFDA/Transparency/track/ucm206804 FDA-TRACK CBER Offices Dashboard word text word defintion ਍††਍਍਍਍਍਍਍