GlaxoSmithKline (GSK) Consumer Healthcare announced the voluntary recall of 2 lots of Children’s Robitussin® Honey Cough and Chest Congestion DM and 1 lot of Children’s Dimetapp® Cold and Cough due to the inclusion of incorrect dosing cups.
The recalled lots were distributed nationwide between February 5, 2020 and June 3, 2020 and include:
- Children’s Robitussin Honey Cough and Chest Congestion DM; NDC 0031-8760-12; Lot 02177 (Expiration Date January 2022); Lot 02178 (Expiration Date January 2022).
- Children’s Dimetapp Cold and Cough; NDC 0031-2234-19; Lot CL8292 (Expiration Date September 2021).
The affected products contain dosing cups that only have the 20mL graduation markings. The Children’s Robitussin Honey products are missing the 5mL and 10mL graduations on the dosing cup, and the Children’s Dimetapp products are missing the 10mL graduation. According to the Company, “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).”
Children’s Robitussin Honey Cough & Chest Congestion DM contains dextromethorphan HBr 10mg and guaifenesin 100mg per 10mL; it is labeled for use in individuals ≥4 years old. Children’s Dimetapp Cold & Cough contains brompheniramine maleate 2mg, dextromethorphan HBr 10mg, and phenylephrine HCl 5mg per 10mL; it is labeled for use in those aged ≥6 years.
At this time, the Company has not received any adverse events related to this recall. Any recalled product should be discontinued from distribution and quarantined. Adverse reactions due to the recalled product may be reported to the FDA’s MedWatch program.
For more information regarding this recall or to report an adverse event, consumers can contact GSK at (800) 762-4675 or fda.gov.