Mead Johnson
This article was originally published in The Tan Sheet
Executive Summary
Infant formula maker says its request that physicians temporarily halt distribution of Enfamil LactoFree and A.R. sample packs lacking ingredient listing was prompted by FDA. Company says packaging originally met FDA guidelines for distribution to doctors, but agency recently announced new labeling reg interpretation and apparently is concerned about downstream distribution of samples beyond doctors' supervision to infants allergic to milk protein found in the products. Company reps will visit affected physicians' offices and resticker unlabeled products. BMS division recalled LactoFree sample packs from stores for similar labeling issue (1"The Tan Sheet" Aug. 6, p. 9)