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)
Lots: 02177 (Exp. January 2022)
02178 (Exp. January 2022)
Children’s Dimetapp® Cold and Cough (8 oz)
Lot: CL8292 (Exp. September 2021)
These lots were distributed across the country between February 5, 2020 and June 3, 2020 within the United States. GSK Consumer Healthcare has notified wholesalers, distributors, and retailers to arrange the return of any recalled product.
Wholesalers, distributors, and retailers with an existing inventory of recalled batches should stop distribution and quarantine them immediately. Wholesalers, distributors and retailers who have further distributed the recalled product should report any additional accounts or locations the recalled product may have received.
Consumers who have questions about this recall or to report an adverse experience should call 1-800-762-4675, Monday through Friday, 8:00 am to 6:00 pm EST.
Consumers should contact their doctor or healthcare provider if they have experienced problems related to taking or using this product.
Adverse reactions or quality problems experienced with the use of this product can be reported to the FDA MedWatch Adverse Event Reporting Program online, by mail, or by fax.
In December 2018, GlaxoSmithKline plc entered into an agreement with Pfizer, Inc. to combine its consumer health businesses into a new joint venture. August 1, 2019 was the first day of the new GSK Consumer Healthcare joint venture. Therefore, when identifying the affected product, please note that the Pfizer company name will still be on the label.