Washington DC- The Food and Drug Administration (FDA) indicated that GSK Consumer Healthcare is voluntarily recalling two batches of Children’s Robitussin® Honey Cough and Chest Congestion DM and one batch of Children’s Dimetapp. ® Cold and Cough, due to the inclusion of incorrect dosing cups.
During the review of the packaging documents for these products, GSK discovered that the dosing cups for the Children’s Robitussin® Honey product lack the 5 ml and 10 ml measurements, while in the dosing cups for the Children’s Dimetapp® product the 10 ml measure is missing. The measuring cups packaged with both products only have a graduation of 20 ml.
The FDA explained that this represents a potential risk of accidental overdose if doctors who dispense the syrup do not notice discrepancies between the graduations printed on the dosing cups and the stated amounts to be administered (as indicated in the instructions for use).
As of the date of the recall announcement, GSK Consumer Healthcare has not received any notification of an adverse event related to these products or consumer complaints regarding the incorrect dosing cups supplied with the product.
The recall is limited to the three batches listed below:
Children’s Robitussin® Honey Tough and Chest Congestion DM (4oz)
NDC 0031-8760-12
Lots: 02177 (Exp. January 2022)
02178 (Exp. January 2022)
Children’s Dimetapp® Cold and Cough (8 oz)
NDC 0031-2234-19
Lot: CL8292 (Exp. September 2021)