GSK Consumer Healthcare is voluntarily recalling to the retail level lots of children's Robitussin and Dimetapp, due to the inclusion of incorrect dosing cups.
During the review of the packaging documents, the drugmaker discovered that 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.
There is a potential risk of accidental overdose if those dispensing the syrup do not notice the discrepancies between the graduations printed on the dosing cups and the indicated amounts to be administered.
The lots — two of Robitussin Honey Cough and Chest Congestion DM (4oz) and one of Dimetapp Cold and Cough (8oz) — were distributed nationwide between February 5, 2020 and June 3, 2020 within the U.S.
Because GSK and Pfizer launched a joint consumer health care venture last August, the packaging of the recalled products still bears Pfizer's name.
Read the FDA alert