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Executive Summary

BARRE-NATIONAL RECALLING OTC CHILDREN's LIQUID ACETAMINOPHEN because the product contains a measuring cup that may result in overdosages. The Class II recall, set to have begun on Dec. 23, follows a Nov. 27 warning letter concerning the acetaminophen product and OTC pediatric liquid pseudoephedrine HCl, which the firm manufactures and packages as generic products under various private labels. Barre-National is a unit of A.L. Labs. The warning letter states that "FDA recently became aware of reports of accidental overdosages attributed, in part, to the incompatible/misleading nature of the measured dosage cups that are supplied with the above referenced drug products, and the labeled dosage directions for these products." The dosage cups "do not bear a 2-teaspoonful graduation to correspond to the '2- teaspoonful' and '2 1/2 teaspoonful' dosage directions specified for the labeling for the OTC pediatric liquid acetaminophen products," the warning letter says. FDA visited Barre-National in mid-November in response to a consumer complaint that involved the administration to a child of two tablespoons of acetaminophen instead of two teaspoons, Barre- National's outside counsel McKenna & Cuneo said. After FDA's visit, the company stopped selling the acetaminophen and pseudoephedrine products. Responding to the warning letter Dec. 19, Barre-National said that although it "has decided to recall the children's acetaminophen product, we would like to reiterate our strong opposition to the agency's determination that our [product] containing a liquid measuring device poses an adverse health consequence to consumers, and therefore necessitates a regulatory recall." Barre informed FDA that it intends to "redesign the liquid measuring devices for all of its products." Barre-National will not be recalling its pseudoephedrine HCl because it is "aware of no safety issue surrounding the marketing of [the pseudoephedrine product]," the firm's response says. Also, the measuring device "corresponds to the labeled dosage directions in terms of teaspoonfuls and milliliters." FDA became aware that incompatibility between product labeling and measuring devices may be an industry-wide problem and issued a Dec. 9 letter to all registered drug establishments. The agency requests that companies "review the labeling of all drug products marketed with an accompanying dosage delivery device to determine if such labeling is compatible with the markings on the dosage device, and make corrections where necessary."

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