Novis PR LLC has issued a recall of 1 lot of G-Supress DX Pediatric Drops Cough Suppressant Nasal Decongestant Cherry Flavor because it contains the wrong product inside the carton packaging.
The Company has received reports of packages marked as the cough suppressant containing Finafta Anesthetic/Analgesic Liquid, a product not manufactured by Novis. Finafta Anesthetic/Analgesic Liquid contains 60% ethyl alcohol and 5% benzocaine and is used to temporarily relieve mouth irritations and inflammation. It is supplied in 15mL bottles.
Children who ingest Finafta are at increased risk of serious adverse events including alcohol toxicity, hypoglycemia, coma, hypothermia, or death. Benzocaine ingestion also carries significant safety risks such as the possibility of methemoglobinemia.
The Food and Drug Administration (FDA) is warning consumers not to purchase Lot# D20911 of G-Supress DX Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant Cherry Flavor with an expiration date of 10/25. The product was only distributed in Puerto Rico.
At this time, there have been no reports of adverse events related to this recall. Consumers can contact Novis at 787-767-2072. Adverse events should also be reported to the FDA’s MedWatch program.
- Food and Drug Administration. G-Supress DX Pediatric Cough Drops may have incorrect drug in packaging. May 22, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/g-supress-dx-pediatric-cough-drops-may-have-incorrect-drug-packaging.
- Food and Drug Administration. Novis PR LLC issues voluntary recall of G-Supress DX Pediatric Drops Due to incorrect packaging. May 19, 2023. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novis-pr-llc-issues-voluntary-recall-g-supress-dx-pediatric-drops-due-incorrect-packaging.