  
 ANNEX B  
 
Content of Recall Status Reports  
 
Recall status reports required under Section VI, Subsection C.3. shall contain the following 
information at the minimum : 
 
A. Name and number of establishments, date, and method of  notification;  
 
B. Name and number of establishments responding to the recall communication and quantity  of 
health products on hand at the time it was  received;  
 
C. Name and number of establishments that did not respond (if needed, the identity of the non - 
responding consignees may be requested by the  FDA);  
 
D. Name and number of health products returned/accounted by each  establishment  
communicated;  
 
E. Results of effectiveness checks by  MAH;  
 
F. Estimated time of completion of the  recall;  and 
 
G. How the health product is being  quarantined;  
 
In addition to the abovementioned information:  
 
H. The initial status report shall contain details on the media announcement for Class I and  II 
MAH – initiated recalls, Class III;  and 
 
I. The final status report shall  contain:  
 
1. Details on the final disposition of the recalled health products including destruction of 
warranted; and   
2. Final  invento ry   
  