definiens: means the US Food and Drug Administration means:10122 - 0321 - 05 Factive ® ( gemifloxacin mesylate ) Tablets 320 mg 5 Tablet in 1 Blister Pack10122 - 0321 - 07 Factive ® ( gemifloxacin mesylate ) Tablets 320 mg 7 Tablet in 1 Blister Pack10122 - 0321 - 01 Factive ® ( gemifloxacin mesylate ) Tablets 320 mg 1 Tablet in 1 Blister Pack with respect to any Product, shall mean a, or or, as thoseterms are defined in the Recall Procedures, and shall include any post - sale warning or mailing of informationregarding such Product, including those warning or mailings described in the Recall Procedures