July 09, 2020
Incorrect dosing cups have prompted GSK Consumer Healthcare to voluntarily recall two lots of Children's Robitussin Honey Cough and Chest Congestion DM and one lot of Children's Dimetapp Cold and Cough. The recalls were included in the July 8, 2020, US Food and Drug Administration (FDA) Enforcement Report.
“During the review of the packaging documents for these products, GSK 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,” GSK stated in a June 18, 2020, company announcement. “The dosing cups packaged with both products only have the 20-mL graduation.”
The recall affects 132,336 bottles of Children’s Robitussin Honey Cough and Chest Congestion DM, 4-ounce bottles (UPC 50300318760128, NDC 0031-8760-12) from lots 02177 and 02178 (Exp. 1/22).
Also recalled are 78,132 bottles of Children’s Dimetapp Cold and Cough, 8-ounce bottles (UPC 60300312234196, NDC 0031-2234-19) from lot CL8292 (Exp. 9/21).
The recalled products were distributed by Pfizer throughout the United States between February 5, 2020, and June 3, 2020. GSK Consumer Healthcare initiated the recalls June 16, 2020. The FDA designated both recalls Class II on June 26, 2020, communicating use of the medications may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
“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 GSK Consumer Healthcare announcement stated. “Children's Robitussin Honey Cough & Chest Congestion DM contains 10 mg dextromethorphan HBr USP and guaifenesin USP 100 mg per 10 mL, and is labeled for children 4 and older, as well as adults. Children's Dimetapp Cold & Cough contains 2 mg brompheniramine maleate USP, 10 mg dextromethorphan HBr USP, and 5 mg phenylephrine HCl USP per 10 mL, and is labeled for children 6 and older, as well as adults.”
Both products are available without a prescription.