Last Updated on October 10, 2024 by The Health Master
San Juan, PR, Novis PR LLC is voluntarily recalling Lot D20911 Exp 10/25 of G-Supress DX Pediatric Drops to the consumer level.
Some cartons of the product have been found to contain incorrect product inside. Incorrect product inside is an anesthetic / analgesic and not a brand of Novis PR LLC.
Anesthetic / Analgesic product contains 60% ethyl alcohol and 5% benzocaine. There is a probability of serious adverse events with a product containing alcohol including alcohol toxicity.
Infants and young children are prone to profound hypoglycemia coma, and hypothermia from ingesting relatively small amounts of ethanol, and deaths have been reported.
Furthermore, the product contains benzocaine but does not include a Warning for methemoglobinemia which is a condition in which too little oxygen is delivered to your cells that can be life-threatening. To date, Novis PR LLC has not receive d any reports of adverse events or injuries related to this recall.
G-Supress DX Pediatric Drops is a cough suppressant, expectorant and nasal decongestant used for the temporarily relief of the common cold symptoms, supplied in 1 oz. bottles packaged in a carton box.
Oral anesthetic/analgesic liquid used for temporary relief for the mouth and gums supplied in 0.5 fl. oz. (15 mL) bottles. Lot D20911 was distributed among pharmacies in Puerto Rico.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (USFDA).
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