A voluntary, nationwide recall has been issued by GSK Consumer Healthcare for children's cough medicines because of incorrectly labeled dosage cups.
The affected items include two lots of Children's Robitussin Honey Cough and Chest Congestion DM (lots 02177 (Exp. Jan. 2022) and 02178 (Exp. Jan. 2022)) and one lot of Children's Dimetapp Cold and Cough (lot CL8292 (Exp. Sep. 2021).
Credit: GSK Consumer Healthcare/FDA
Credit: GSK Consumer Healthcare/FDA
The company discovered the dosage cup issue during the review of the packaging documents for the products. It was discovered that the dosing cups for the Children's Robitussin Honey product are missing the 5 mL and 10 mL graduations. The dosing cups for the Children's Dimetapp product are missing the 10 mL graduation.
“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),” the recall announcement said.
The company said the lots were distributed nationwide between February 5, 2020, and June 3, 2020, in the United States. GSK Consumer Healthcare notified wholesalers, distributors and retailers to arrange for return of the recalled products.
“As of the date of the recall announcement, GSK Consumer Healthcare has not received any adverse events related to these products or consumer complaints regarding the incorrect dosing cups supplied with the product,” the announcement said.
Consumers with questions about the recall, or who want to report an adverse experience, are asked to call the GSK Contact Center at 1-800-762-4675, Monday – Friday, 8 a.m. – 6 p.m. EDT.
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