Class I Recall for Children’s OTC Cold Medicine

A product mix-up has prompted a Class I recall for a single lot of over-the-counter G-Supress DX Pediatric Drops, a cough suppressant, expectorant, and nasal decongestant product manufactured by Novis PR LLC. The recalled medication was distributed to pharmacies in Puerto Rico.

According to a May 22, 2023, announcement from the US Food and Drug Administration (FDA), Novis has received reports that the wrong product, Finafta Anesthetic/Analgesic Liquid, was inside some G-Supress cartons. Finafta Anesthetic/Analgesic Liquid, which is not manufactured by Novis, contains 60% ethyl alcohol and 5% benzocaine and is used to temporarily relieve mouth irritations and inflammation. 

“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,” the FDA warned. “Benzocaine can cause methemoglobinemia, a potentially life-threatening condition where too little oxygen is delivered to your cells.”

Novis PR voluntarily initiated the recall April 20, 2023. On June 6, 2023, the FDA designated the recall Class I, a designation that warns use of the affected product could cause serious adverse health consequences or death.

The recall affects 9077 bottles of cherry-flavored G-Supress DX (dextromethorphan HBr, guaifenesin, phenylephrine HCl) Pediatric Drops in 1-ounce bottles, packaged in a carton box (NDC 52083-655-01), from lot D20911 (Exp 10/25). The recall was included in the June 7, 2023, FDA Enforcement Report.