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)
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Mead Johnson
Enfamil LactoFree infant formula sample packs distributed to 30 Babies R Us stores in nine states recalled for failure to list ingredients on packaging. Sample packs contain two 3-oz., ready-to-use Nursette bottles and two Easy One single-serve packets; labeling failed to note products contain milk proteins, which can cause allergic reactions. Only six of 900 packs remain unaccounted for, firm says. Mead has begun shipping newly labeled product and has relabeled old packs in affected stores. Recall is second action by Mead in past month; in July, the BMS division undertook a "field correction" and ad campaign concerning labeling discrepancies on Nutramigen formula (1"The Tan Sheet" July 16, p. 8)
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In Brief
Combe sells most of its OTC brands