Create a Report
Please provide report title
Please provide location
Please provide details
Get alerts and updates for your case!
This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.
Please provide email or phone
Please provide email or phone

We do not show your email or contact info

Please accept our Terms & Conditions
Add photos or video
We recommend photos and videos to help explain your report
Add Photo/Video
Email or SMS copy of report
Enter below to get emailed a copy of your report, or sms a link to your report
Please provide email or phone
Please provide email or phone
Please accept our Terms & Conditions
Thank you for your report!


IMPORTANT - Your report is queued
It may take up to 12 hours to process your report.


Email us at support@safelyhq.com if you have questions.

Report by
Loading...
Please provide location
Please provide location
Please provide report title
Please provide details
Please accept our Terms & Conditions
Get alerts and updates for your case! Your contact information is not shown on the website.

This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.

or
Please provide email or phone
Thank you for your report!

IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

Visit our learn pages for more helpful information or, email us: support@safelyhq.com

Goodbye! and best wishes in your recovery

GlaxoSmithKline

Updated: June 18, 2020 11:00 PM
Company name: GSK Consumer Healthcare
Brand name: Robitussin
Product recalled: Cough and cold products
Reason of the recall: Incorrect dosing cups
FDA Recall date: June 18, 2020
Recall details: GSK Consumer Healthcare is voluntarily recalling to the retail level two lots (listed below) of Children's Robitussin® Honey... See More Cough and Chest Congestion DM and one lot of Children's Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups. 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. The dosing cups packaged with both products only have the 20 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). 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.

Symptoms of overdose of either product may include any of the following: impaired coordination; brain stimulation causing increase in energy, elevation in blood pressure, heart rate, and respiration; a lack of energy and enthusiasm; severe dizziness or drowsiness; slow heart rate; fainting; psychotic behaviour; restlessness; seizure; decreased respiration; nausea; vomiting; constipation; diarrhea; abdominal pain; visual and hearing hallucinations; urinary retention.

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 recall is limited to the three lots listed below:

Children's Robitussin® Honey Cough and Chest Congestion DM (4oz)
NDC 0031-8760-12
Lots: 02177 (Exp. Jan. 2022) / 02178 (Exp. Jan. 2022)

Children's Dimetapp® Cold and Cough (8oz)
NDC 0031-2234-19
Lot: CL8292 (Exp. Sep. 2021)

These lots were distributed nationwide between February 5, 2020 and June 3, 2020 within the United States. GSK Consumer Healthcare has notified wholesalers, distributors and retailers to arrange for return of any recalled product. Wholesalers, distributors and retailers with an existing inventory of the lots being recalled should stop distribution and quarantine these lots immediately.

Wholesalers, distributors and retailers that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. In December 2018, GlaxoSmithKline plc reached an agreement with Pfizer, Inc. to combine their consumer health businesses into a new Joint Venture. August 01, 2019 was the first day of the new GSK Consumer Healthcare Joint Venture. Thus, when identifying impacted product, please be aware the Pfizer company name will still be present on the label.

Check the full recall details on fda.gov

Source: FDA
See Less
303


Recent Interesting Reports

On 13/02/2024 I paid an amount of 492.26 MAD for a telephone. But no phone received??? Where is my phone that I bought?? See Less


I ordered the 3 bras and they are too small, plus a plastic support was coming out. I was really sad about the fit.
I ordered 3 bras and I just received them and the are too small. After reading your reports, I guess that I won't... See More get a refund from Heathers Motty. Guess I just learned a costly lesson. See Less


I received merchandise from this company, with no return slip. I did not order from them. I ordered from Hatmeo. They did not say they were an overseas company Xentai Tech Limi Hong Kong Airwalle. To many companies. I need a return slip or a refund. See Less


I ordered knives since August 22, 2023 in the amount of 49.99 US never received and on the tracking it is written delivered and I tried again to write to them because I have already succeeded and now it is written See Less


What I thought was going on I was subscribing to Paramount I end up paying $159 for something I did not even know what was coming in the mail. It's a white powdered look like it could be detergent powder I'm trashing it. They already have too... See More much of my information. I have had to cancel my debit card and get another one. When I researched them it was a U-Haul truck look like a bandit Warehouse. See Less
256


Receive a package that I did not order. Opend it to find 2 blue thin dots that have sticky on one side. Have no idea what they're for. They came from geathers fottys See Less
16


I ordered licensce plate flipper for my show car. The item was listed for $29.97 but I received a cheap clear license plate cover from a dollar store. See Less
2.8K


Last 30 days