[5/22/2023] FDA is alerting consumers and pharmacies to not use or sell a specific lot of over-the-counter G-Supress DX Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant Cherry Flavor, manufactured by Novis PR LLC, because it contains the incorrect product and may cause patient harm.
Novis received multiple complaints from pharmacies that found the wrong product – Finafta Anesthetic/Analgesic Liquid – inside the carton packaging of the G-Supress product. Novis does not manufacture Finafta Anesthetic/Analgesic Liquid, used to temporarily relieve mouth irritations and inflammation. Finafta Anesthetic/Analgesic Liquid comes in 0.5-fl. oz. (15-mL) bottles.
Finafta Anesthetic/Analgesic Liquid contains 60% ethyl alcohol and 5% benzocaine. Infants and young children are at higher risk of developing alcohol toxicity, profound hypoglycemia (low blood sugar), coma, hypothermia (low body temperature), or death from ingesting even relatively small amounts of ethanol. Benzocaine can cause methemoglobinemia, a potentially life-threatening condition where too little oxygen is delivered to your cells.
Novis issued a voluntary recall (also in Spanish) of Lot D20911 Exp 10/25 of G-Supress DX Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant Cherry Flavor. Consumers, distributors, and retailers should stop using this lot and return it to place of purchase. The product was only distributed in Puerto Rico. To date, Novis has not received any reports of adverse events or injuries related to product use.
Novis is notifying its distributors and customers by email and telephone calls and arranging return of the recalled lot. Consumers with questions regarding this recall can contact Novis PR LLC at 787-767-2072 Monday through Friday from 8:00 am – 4:00 pm EDT.
Consumers should contact their physician or health care professional if they have experienced any problems that may be related to taking or using this drug.
FDA encourages health care professionals and consumers to report adverse events or quality problems with these or any medications to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.