G-Supress DX Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant Cherry Flavor, manufactured by Novis PR LLC, has been recalled. The Food and Drug Administration has issued an alert advising consumers and pharmacies to immediately stop using and selling specific lots of the over-the-counter children’s cough suppressant.
The recall was initiated after Novis received grievances from pharmacies stating that the wrong product was included in the G-Supress DX Pediatric Drops Cough Suppressant packaging. Instead, the packaging contained Finafta Anesthetic/Analgesic Liquid, a product not manufactured by Novis.
Finafta is manufactured by Dextrum Laboratories Inc. for the temporary relief of canker sores. The product, which is not intended for children, lists an ethyl alcohol content of 60% and also contains 5% benzocaine. According to the FDA, ethanol intoxication in children can lead to “developing alcohol toxicity, profound hypoglycemia (low blood sugar), coma, hypothermia (low body temperature), or death from ingesting even relatively small amounts of ethanol”. In infants and young children, ingestion of benzocaine can lead to methemoglobinemia, which can be life-threatening. Methemoglobinemia occurs when the tissues cannot receive enough oxygen.
What lots are affected by the G-Supress DX Pediatric Drops recall?
Novis has issued a voluntary recall of Lot D20911 of G-Supress DX Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant Cherry Flavor with an expiration of October 2025.
What should consumers do if they have purchased G-Supress DX Pediatric Drops?
Consumers are advised to immediately stop using the product and call a trusted medical professional. The product should then be returned to the store where it was purchased for a full refund. According to Novis, reported deaths are not tied to this recall. Those bottles were distributed in Puerto Rico.
If consumers have questions about affected products, they should contact Novis PR LLC at 787-767-2072, Monday through Friday, from 8:00 am to 4:00 pm EDT. Consumers who have experienced adverse reactions to this product are encouraged by the FDA to immediately report serious problems through their MedWatch Adverse Event Reporting program.
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Sources:
https://www.cancer.gov/publications/dictionaries/cancer-terms/def/methemoglobinemia
https://www.miamiherald.com/news/recalls/article275636036.html?ac_cid=DM802173&ac_bid=-1301306115
