A manufacturer of children’s cold and cough medicine has issued a recall after officials discovered incorrect dosing cups were included in the packaging.
The Food and Drug Administration (FDA) said, “GSK Consumer Healthcare is voluntarily recalling to the retail level two lots of Children’s Robitussin® Honey Cough and Chest Congestion DM and one lot of Children’s Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups.”
During a review of the packaging documents for these products, the FDA reports GSK discovered the dosing cups for the Children’s Robitussin® Honey product are missing the 5 mL and 10 mL graduations, while the dosing cups for the Children’s Dimetapp® product are missing the 10 mL graduation. The dosing cups packaged with both products only have the 20 mL graduation.
Officials said there is a potential risk of accidental overdose if caregivers dispensing the syrup do not notice the discrepancies between the graduations printed on the dosing cups and the indicated amounts to be administered (as directed in the instructions for use).
Symptoms of overdose of either product, according to the FDA, may include any of the following: impaired coordination; brain stimulation causing increase in energy, elevation in blood pressure, heart rate, and respiration; a lack of energy and enthusiasm; severe dizziness or drowsiness; slow heart rate; fainting; psychotic behavior; restlessness; seizure; decreased respiration; nausea; vomiting; constipation; diarrhea; abdominal pain; visual and audio hallucinations; and urinary retention.
The recall is limited to the three lots listed below:
Children’s Robitussin® Honey Cough and Chest Congestion DM (4oz)
NDC 0031-8760-12
Lot: 02177 (Exp. Jan. 2022)
Lot: 02178 (Exp. Jan. 2022)
Children’s Dimetapp® Cold and Cough (8oz)
NDC 0031-2234-19
Lot: CL8292 (Exp. Sep. 2021)
These lots were distributed nationwide between February 5, 2020 and June 3, 2020.
Consumers with questions regarding this recall or to report an adverse experience please call 1-800-762-4675, Monday through Friday between 8:00 a.m. and 6:00p.m. eastern standard time.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
By Ken Howlett, News Director
Contact Ken at ken@k105.com
