Safety Report: G-SUPRESS DX pediatric drops- recalled due to Incorrect Packaging, Puerto Rico

Puerto Rico

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. Lot D20911 was distributed among pharmacies in Puerto Rico. To date, Novis PR LLC has not receive d any reports of adverse events or injuries related to this recall.

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.

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.

Novis PR LLC is notifying its distributors and customers by email and telephone calls and arranging return of recalled lot.  Consumers/distributors/retailers that have affected lot should stop using and return to place of purchase. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: NOVIS PR LLC
Brand name: G-SUPRESS DX
Product recalled: Cough Suppressant, expectorant, nasal decongestant pediatric drops
Reason of the recall: Device & Drug Safety/Mislabeling
FDA Recall date: May 19, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novis-pr-llc-issues-voluntary-recall-g-supress-dx-pediatric-drops-due-incorrect-packaging