definiens: . O.r as such terms are defined in 21 C.F.R. Part 7.3, O.fthe CO.-PrO.mO.tiO.n CO.llabO.ratiO.n PrO.duct in the United States ( ) O.r a O.r, as such terms are defined in 21 C.F.R. Part 7.3, O.fthe CO.-PromO.tiO.n CO.llabO.ratiO.n PrO.duct in the United States that is limited in territOlYO.r as to ' any lO.t(s ) O.r batches O.f the CO.­PromO.tiO.n CO.llabOratiO.n PrO.duct ( andcO.llectively with Pennanent Recall, a . ) .