Children’s Robitussin, Dimetapp Recalled Due to Overdose Risk

June 29, 2020 - FDA recently announced that GSK Consumer Healthcare voluntarily recalled two lots of Children’s Robitussin and one lot of Children’s Dimetapp due to the inclusion of incorrect dosing cups. 

GSK specifically recalled Children’s Robitussin Honey Cough & Chest Congestion DM and Children’s Dimetapp Cold & Cough after they were distributed nationwide between February 5, 2020, and June 3, 2020, within the US.

After review of the packaging documents, GSK found that dosing cups for Honey Cough & Chest Congestion was missing the 5ml and 10ml graduations and dosing cups for the Cold & Cough were missing the 10ml graduation.

Dosing cups packaged with both products only contained the 20ml graduation.

GSK noted that there is a potential risk of accidental overdose if caregivers giving a child the medicine do not notice the discrepancies between the graduations printed on the dosing cups and the indicated amounts to be administered. 

Children's Robitussin Honey Cough & Chest Congestion DM contains 10mg dextromethorphan HBr USP and guaifenesin USP 100 mg per 10 mL, while 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, GSK stated. 

The Honey Cough & Chest Congestion DM is intended for children four and older, as well as adults. The Cold & Cough medicine is labeled for children six and older, as well as adults.  

Overdosing symptoms include impaired coordination, elevation in blood pressure, heart rate, and respiration, dizziness or drowsiness, and slow heart rate. 

As of the date of the recall announcement, GSK had not received any adverse events related to these products or consumer complaints regarding the incorrect dosing cups supplied with the product.

GSK noted that the company has notified wholesalers, distributors, and retailers to arrange for return of any recalled product. 

Additionally, any wholesalers, distributors, and retailers with an existing inventory of the lots being recalled should stop distribution and quarantine these lots immediately and should notify any accounts or additional locations that may have received the recalled product from them.

This isn’t the first time GSK had to recall one of its products. Last October, the company recalled its popular heartburn product, ranitidine (Zantac) in all markets after FDA found “unacceptable” levels of N-Nitrosodimethylamine (NDMA) in the drug.  

NDMA is being considered a human carcinogen that, at sustained higher levels, could increase the risk of cancer in humans. 

In April, FDA requested manufacturers withdraw all prescriptions and over-the-counter (OTC) Zantac drugs from the market as its last step in an ongoing investigation of NDMA in the medication.

FDA testing and evaluation prompted by information from third-party laboratories confirmed that NDMA levels increase in ranitidine even under normal storage conditions, the agency stated.

Additionally, the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.

“Since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured,” Janet Woodcock, MD, director of FDA’s center for drug evaluation and research, said in the announcement.

“The FDA will continue our efforts to ensure impurities in other drugs do not exceed acceptable limits so that patients can continue taking medicines without concern.”

As a result of the immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the US.