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<measures><measure><type>Main</type><parent-measure></parent-measure><title>Total number of recall events in the month for which the classification process was completed</title><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.</dictionary>
<dictionary>&lt;br&gt;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. &lt;/b&gt;</dictionary>
<measure-description>Number</measure-description><chart-type></chart-type><chart-color></chart-color><right-min></right-min><right-max></right-max><fiscal-year><chart-min></chart-min><chart-max></chart-max><title>2010</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct 2009</frame><target></target><value>20</value></time><time><frame>Nov 2009</frame><target></target><value>23</value></time><time><frame>Dec 2009</frame><target></target><value>5</value></time><time><frame>Jan 2010</frame><target></target><value>9</value></time><time><frame>Feb 2010</frame><target></target><value>8</value></time><time><frame>Mar 2010</frame><target></target><value>37</value></time><time><frame>Apr 2010</frame><target></target><value>24</value></time><time><frame>May 2010</frame><target></target><value>16</value></time><time><frame>Jun 2010</frame><target></target><value>32</value></time><time><frame>Jul 2010</frame><target></target><value>20</value></time><time><frame>Aug 2010</frame><target></target><value>26</value></time><time><frame>Sep 2010</frame><target></target><value>38</value></time></fiscal-year><fiscal-year><chart-min></chart-min><chart-max></chart-max><title>2011</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct 2010</frame><target></target><value>15</value></time><time><frame>Nov 2010</frame><target></target><value>23</value></time><time><frame>Dec 2010</frame><target></target><value>34</value></time><time><frame>Jan 2011</frame><target></target><value>19</value></time><time><frame>Feb 2011</frame><target></target><value>31</value></time><time><frame>Mar 2011</frame><target></target><value>47</value></time><time><frame>Apr 2011</frame><target></target><value>35</value></time><time><frame>May 2011</frame><target></target><value>16</value></time><time><frame>Jun 2011</frame><target></target><value>47</value></time><time><frame>Jul 2011</frame><target></target><value>41</value></time><time><frame>Aug 2011</frame><target></target><value>71</value></time><time><frame>Sep 2011</frame><target></target><value>40</value></time></fiscal-year></measure>
<related-links><link><url>http://www.fda.gov/AboutFDA/Transparency/track/ucm206444.htm</url><text>FDA-TRACK CDER Dashboard</text></link></related-links>
<measure><type>Sub</type><parent-measure>Total number of recall events in the month for which the classification process was completed</parent-measure><title>Number of Class I recalls classified by Office of Regulatory Affairs (ORA) after recommendation by CDER Compliance (1)</title><dictionary></dictionary><footnotes><note>(1) Authority to designate a drug recall as Class I currently rests with the Associate Commissioner for Regulatory Affairs (ACRA)</note></footnotes><measure-description>Number</measure-description><chart-type></chart-type><chart-color></chart-color><right-min></right-min><right-max></right-max><fiscal-year><chart-min>0</chart-min><chart-max>75</chart-max><title>2010</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct 2009</frame><target></target><value>0</value></time><time><frame>Nov 2009</frame><target></target><value>2</value></time><time><frame>Dec 2009</frame><target></target><value>1</value></time><time><frame>Jan 2010</frame><target></target><value>0</value></time><time><frame>Feb 2010</frame><target></target><value>1</value></time><time><frame>Mar 2010</frame><target></target><value>3</value></time><time><frame>Apr 2010</frame><target></target><value>3</value></time><time><frame>May 2010</frame><target></target><value>3</value></time><time><frame>Jun 2010</frame><target></target><value>4</value></time><time><frame>Jul 2010</frame><target></target><value>2</value></time><time><frame>Aug 2010</frame><target></target><value>2</value></time><time><frame>Sep 2010</frame><target></target><value>8</value></time></fiscal-year><fiscal-year><chart-min>0</chart-min><chart-max>75</chart-max><title>2011</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct 2010</frame><target></target><value>3</value></time><time><frame>Nov 2010</frame><target></target><value>2</value></time><time><frame>Dec 2010</frame><target></target><value>4</value></time><time><frame>Jan 2011</frame><target></target><value>4</value></time><time><frame>Feb 2011</frame><target></target><value>3</value></time><time><frame>Mar 2011</frame><target></target><value>2</value></time><time><frame>Apr 2011</frame><target></target><value>7</value></time><time><frame>May 2011</frame><target></target><value>2</value></time><time><frame>Jun 2011</frame><target></target><value>4</value></time><time><frame>Jul 2011</frame><target></target><value>0</value></time><time><frame>Aug 2011</frame><target></target><value>8</value></time><time><frame>Sep 2011</frame><target></target><value>4</value></time></fiscal-year></measure><measure><type>Sub</type><parent-measure>Total number of recall events in the month for which the classification process was completed</parent-measure><title>Percent Class 1 recall events from tainted supplements</title><dictionary></dictionary><footnotes><note></note></footnotes><measure-description>Percent</measure-description><chart-type></chart-type><chart-color></chart-color><right-min></right-min><right-max></right-max><fiscal-year><chart-min>0</chart-min><chart-max>100</chart-max><title>2011</title><target-header></target-header><target-description>Performance measure implemented FY 2011</target-description><summary></summary><time><frame>Oct 2010</frame><target></target><value>67</value></time><time><frame>Nov 2010</frame><target></target><value>0</value></time><time><frame>Dec 2010</frame><target></target><value>75</value></time><time><frame>Jan 2011</frame><target></target><value>100</value></time><time><frame>Feb 2011</frame><target></target><value>33</value></time><time><frame>Mar 2011</frame><target></target><value>100</value></time><time><frame>Apr 2011</frame><target></target><value>57</value></time><time><frame>May 2011</frame><target></target><value>100</value></time><time><frame>Jun 2011</frame><target></target><value>TBA</value></time><time><frame>Jul 2011</frame><target></target><value>0</value></time><time><frame>Aug 2011</frame><target></target><value>63</value></time><time><frame>Sep 2011</frame><target></target><value>50</value></time></fiscal-year></measure><measure><type>Sub</type><parent-measure>Total number of recall events in the month for which the classification process was completed</parent-measure><title>Number of products impacted by Class I recalls</title><dictionary></dictionary><measure-description>Number</measure-description><chart-type></chart-type><chart-color></chart-color><right-min></right-min><right-max></right-max><fiscal-year><chart-min>0</chart-min><chart-max>75</chart-max><title>2010</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct 2009</frame><target></target><value>0</value></time><time><frame>Nov 2009</frame><target></target><value>2</value></time><time><frame>Dec 2009</frame><target></target><value>1</value></time><time><frame>Jan 2010</frame><target></target><value>0</value></time><time><frame>Feb 2010</frame><target></target><value>1</value></time><time><frame>Mar 2010</frame><target></target><value>7</value></time><time><frame>Apr 2010</frame><target></target><value>8</value></time><time><frame>May 2010</frame><target></target><value>12</value></time><time><frame>Jun 2010</frame><target></target><value>66</value></time><time><frame>Jul 2010</frame><target></target><value>2</value></time><time><frame>Aug 2010</frame><target></target><value>30</value></time><time><frame>Sep 2010</frame><target></target><value>29</value></time></fiscal-year><fiscal-year><chart-min>0</chart-min><chart-max>75</chart-max><title>2011</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct 2010</frame><target></target><value>4</value></time><time><frame>Nov 2010</frame><target></target><value>2</value></time><time><frame>Dec 2010</frame><target></target><value>6</value></time><time><frame>Jan 2011</frame><target></target><value>29</value></time><time><frame>Feb 2011</frame><target></target><value>3</value></time><time><frame>Mar 2011</frame><target></target><value>2</value></time><time><frame>Apr 2011</frame><target></target><value>8</value></time><time><frame>May 2011</frame><target></target><value>2</value></time><time><frame>Jun 2011</frame><target></target><value>5</value></time><time><frame>Jul 2011</frame><target></target><value>0</value></time><time><frame>Aug 2011</frame><target></target><value>25</value></time><time><frame>Sep 2011</frame><target></target><value>5</value></time></fiscal-year></measure><measure><type>Sub</type><parent-measure>Total number of recall events in the month for which the classification process was completed</parent-measure><title>Percent of products impacted that are tainted supplements</title><dictionary></dictionary><footnotes><note></note></footnotes><measure-description>Percent</measure-description><chart-type></chart-type><chart-color></chart-color><right-min></right-min><right-max></right-max><fiscal-year><chart-min>0</chart-min><chart-max>100</chart-max><title>2011</title><target-header></target-header><target-description>Performance measure implemented FY 2011</target-description><summary></summary><time><frame>Oct 2010</frame><target></target><value>75</value></time><time><frame>Nov 2010</frame><target></target><value>0</value></time><time><frame>Dec 2010</frame><target></target><value>67</value></time><time><frame>Jan 2011</frame><target></target><value>100</value></time><time><frame>Feb 2011</frame><target></target><value>33</value></time><time><frame>Mar 2011</frame><target></target><value>100</value></time><time><frame>Apr 2011</frame><target></target><value>63</value></time><time><frame>May 2011</frame><target></target><value>100</value></time><time><frame>Jun 2011</frame><target></target><value>60</value></time><time><frame>Jul 2011</frame><target></target><value>0</value></time><time><frame>Aug 2011</frame><target></target><value></value></time><time><frame>Sep 2011</frame><target></target><value></value></time></fiscal-year></measure><measure><type>Sub</type><parent-measure>Total number of recall events in the month for which the classification process was completed</parent-measure><title>Number of Class II recalls classified</title><dictionary></dictionary><measure-description>Number</measure-description><chart-type></chart-type><chart-color></chart-color><right-min></right-min><right-max></right-max><fiscal-year><chart-min>0</chart-min><chart-max>100</chart-max><title>2010</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct 2009</frame><target></target><value>12</value></time><time><frame>Nov 2009</frame><target></target><value>9</value></time><time><frame>Dec 2009</frame><target></target><value>2</value></time><time><frame>Jan 2010</frame><target></target><value>2</value></time><time><frame>Feb 2010</frame><target></target><value>3</value></time><time><frame>Mar 2010</frame><target></target><value>19</value></time><time><frame>Apr 2010</frame><target></target><value>17</value></time><time><frame>May 2010</frame><target></target><value>8</value></time><time><frame>Jun 2010</frame><target></target><value>17</value></time><time><frame>Jul 2010</frame><target></target><value>11</value></time><time><frame>Aug 2010</frame><target></target><value>19</value></time><time><frame>Sep 2010</frame><target></target><value>19</value></time></fiscal-year><fiscal-year><chart-min>0</chart-min><chart-max>100</chart-max><title>2011</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct 2010</frame><target></target><value>9</value></time><time><frame>Nov 2010</frame><target></target><value>17</value></time><time><frame>Dec 2010</frame><target></target><value>15</value></time><time><frame>Jan 2011</frame><target></target><value>10</value></time><time><frame>Feb 2011</frame><target></target><value>19</value></time><time><frame>Mar 2011</frame><target></target><value>28</value></time><time><frame>Apr 2011</frame><target></target><value>20</value></time><time><frame>May 2011</frame><target></target><value>7</value></time><time><frame>Jun 2011</frame><target></target><value>23</value></time><time><frame>Jul 2011</frame><target></target><value>29</value></time><time><frame>Aug 2011</frame><target></target><value>41</value></time><time><frame>Sep 2011</frame><target></target><value>27</value></time></fiscal-year></measure><measure><type>Sub</type><parent-measure>Total number of recall events in the month for which the classification process was completed</parent-measure><title>Number of products impacted by Class II recalls</title><dictionary></dictionary><measure-description>Number</measure-description><chart-type></chart-type><chart-color></chart-color><right-min></right-min><right-max></right-max><fiscal-year><chart-min>0</chart-min><chart-max>100</chart-max><title>2010</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct 2009</frame><target></target><value>21</value></time><time><frame>Nov 2009</frame><target></target><value>88</value></time><time><frame>Dec 2009</frame><target></target><value>2</value></time><time><frame>Jan 2010</frame><target></target><value>2</value></time><time><frame>Feb 2010</frame><target></target><value>3</value></time><time><frame>Mar 2010</frame><target></target><value>25</value></time><time><frame>Apr 2010</frame><target></target><value>30</value></time><time><frame>May 2010</frame><target></target><value>21</value></time><time><frame>Jun 2010</frame><target></target><value>42</value></time><time><frame>Jul 2010</frame><target></target><value>17</value></time><time><frame>Aug 2010</frame><target></target><value>48</value></time><time><frame>Sep 2010</frame><target></target><value>90</value></time></fiscal-year><fiscal-year><chart-min>0</chart-min><chart-max>100</chart-max><title>2011</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct 2010</frame><target></target><value>18</value></time><time><frame>Nov 2010</frame><target></target><value>65</value></time><time><frame>Dec 2010</frame><target></target><value>43</value></time><time><frame>Jan 2011</frame><target></target><value>16</value></time><time><frame>Feb 2011</frame><target></target><value>44</value></time><time><frame>Mar 2011</frame><target></target><value>95</value></time><time><frame>Apr 2011</frame><target></target><value>22</value></time><time><frame>May 2011</frame><target></target><value>59</value></time><time><frame>Jun 2011</frame><target></target><value>42</value></time><time><frame>Jul 2011</frame><target></target><value>121</value></time><time><frame>Aug 2011</frame><target></target><value>93</value></time><time><frame>Sep 2011</frame><target></target><value>693</value></time></fiscal-year></measure><measure><type>Sub</type><parent-measure>Total number of recall events in the month for which the classification process was completed</parent-measure><title>Number of Class III recalls classified</title><dictionary></dictionary><measure-description>Number</measure-description><chart-type></chart-type><chart-color></chart-color><right-min></right-min><right-max></right-max><fiscal-year><chart-min>0</chart-min><chart-max>200</chart-max><title>2010</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct 2009</frame><target></target><value>8</value></time><time><frame>Nov 2009</frame><target></target><value>12</value></time><time><frame>Dec 2009</frame><target></target><value>2</value></time><time><frame>Jan 2010</frame><target></target><value>7</value></time><time><frame>Feb 2010</frame><target></target><value>4</value></time><time><frame>Mar 2010</frame><target></target><value>15</value></time><time><frame>Apr 2010</frame><target></target><value>4</value></time><time><frame>May 2010</frame><target></target><value>5</value></time><time><frame>Jun 2010</frame><target></target><value>11</value></time><time><frame>Jul 2010</frame><target></target><value>7</value></time><time><frame>Aug 2010</frame><target></target><value>5</value></time><time><frame>Sep 2010</frame><target></target><value>11</value></time></fiscal-year><fiscal-year><chart-min>0</chart-min><chart-max>200</chart-max><title>2011</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct 2010</frame><target></target><value>3</value></time><time><frame>Nov 2010</frame><target></target><value>4</value></time><time><frame>Dec 2010</frame><target></target><value>15</value></time><time><frame>Jan 2011</frame><target></target><value>5</value></time><time><frame>Feb 2011</frame><target></target><value>9</value></time><time><frame>Mar 2011</frame><target></target><value>17</value></time><time><frame>Apr 2011</frame><target></target><value>8</value></time><time><frame>May 2011</frame><target></target><value>7</value></time><time><frame>Jun 2011</frame><target></target><value>20</value></time><time><frame>Jul 2011</frame><target></target><value>12</value></time><time><frame>Aug 2011</frame><target></target><value>22</value></time><time><frame>Sep 2011</frame><target></target><value>9</value></time></fiscal-year></measure><measure><type>Sub</type><parent-measure>Total number of recall events in the month for which the classification process was completed</parent-measure><title>Number of products impacted by Class III recalls</title><dictionary></dictionary><measure-description>Number</measure-description><chart-type></chart-type><chart-color></chart-color><right-min></right-min><right-max></right-max><fiscal-year><chart-min>0</chart-min><chart-max>200</chart-max><title>2010</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct 2009</frame><target></target><value>8</value></time><time><frame>Nov 2009</frame><target></target><value>14</value></time><time><frame>Dec 2009</frame><target></target><value>2</value></time><time><frame>Jan 2010</frame><target></target><value>187</value></time><time><frame>Feb 2010</frame><target></target><value>6</value></time><time><frame>Mar 2010</frame><target></target><value>27</value></time><time><frame>Apr 2010</frame><target></target><value>5</value></time><time><frame>May 2010</frame><target></target><value>14</value></time><time><frame>Jun 2010</frame><target></target><value>20</value></time><time><frame>Jul 2010</frame><target></target><value>10</value></time><time><frame>Aug 2010</frame><target></target><value>7</value></time><time><frame>Sep 2010</frame><target></target><value>21</value></time></fiscal-year><fiscal-year><chart-min>0</chart-min><chart-max>200</chart-max><title>2011</title><target-header></target-header><target-description></target-description><summary></summary><time><frame>Oct 2010</frame><target></target><value>3</value></time><time><frame>Nov 2010</frame><target></target><value>7</value></time><time><frame>Dec 2010</frame><target></target><value>19</value></time><time><frame>Jan 2011</frame><target></target><value>14</value></time><time><frame>Feb 2011</frame><target></target><value>25</value></time><time><frame>Mar 2011</frame><target></target><value>33</value></time><time><frame>Apr 2011</frame><target></target><value>12</value></time><time><frame>May 2011</frame><target></target><value>12</value></time><time><frame>Jun 2011</frame><target></target><value>35</value></time><time><frame>Jul 2011</frame><target></target><value>13</value></time><time><frame>Aug 2011</frame><target></target><value>31</value></time><time><frame>Sep 2011</frame><target></target><value>42</value></time></fiscal-year></measure></measures>
    






