FDA warns G-Supress DX Pediatric Cough Drops could have wrong drug in packaging

FDA warns G-Supress DX Pediatric Cough Drops could have wrong drug in packaging | Image Credit: © Balint Radu - © Balint Radu - stock.adobe.com.

The FDA is advising pharmacies and consumers to stop using and selling a specific lot of over-the-counter G-Supress DX Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant Cherry Flavor because it could contain the incorrect product that may cause patient harm, the agency announced in a press release.

Manufacturer Novis PR LLC has received multiple complaints from pharmacies of the wrong product inside the carton packaging of the G-Supress product. Finafta Anesthetic/Analgesic Liquid, a product not manufactured by Novis, has been found in the G-Supress packaging. Finafta Anesthetic/Analgesic Liquid contains 60% ethyl alcohol, 5% benzocaine, and is used to temporarily relieve mouth irritations and inflammation. Finafta Anesthetic/Analgesic Liquid comes in 15 mL bottles, according to the FDA. Infants and young children are at a higher risk of developing alcohol toxicity, profound hypoglycemia, coma, hypothermia, or death from ingesting, “even relatively small amounts of ethanol,” states the FDA. The agency adds that benzocaine can cause methemoglobinemia, a potentially life-threatening condition where not enough oxygen is delivered to cells.

Novis, which issued a voluntary recall of Lot D20911 (Exp October 2025) of G-Supress DX Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant Cherry Flavor, is notifying distributors and customers by email and telephone calls. Consumers, distributors, and retailers should stop using the specific lot and return it to the place of purchase. According to the FDA, the product was being distributed from Puerto Rico. As of May 22, 2023, Novis has not received any reports of adverse events or injuries associated with product use.

Consumers can contact Novis PR LLC at 787-767-2072 Monday through Friday from 8:00am to 4:00pm EDT.

The FDA encourages health care professionals and consumers to report adverse events or quality problems with this or any medication to the FDA’s MedWatch Adverse Event Reporting program. 

Reference:

G-Supress DX Pediatric Cough Drops may have incorrect drug in packaging. FDA. May 22, 2023. Accessed May 23, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/g-supress-dx-pediatric-cough-drops-may-have-incorrect-drug-packaging