• The company received complaints from pharmacies
  • So far, there have been no reports of adverse events related to the recall
  • Those with questions about the recall may contact the company

A company is recalling its over-the-counter pediatric drops after the boxes were found to contain the wrong product. The product that's inside "may cause patient harm."

The problem was discovered after the company, Novis, received "multiple" complaints from pharmacies about the cartons of G-Supress DX Pediatric Drops actually containing another product, the U.S. Food and Drug Administration (FDA) noted in its alert to consumers and pharmacies. Specifically, the cartons contain the Finafta Anesthetic/Analgesic Liquid instead of the pediatric drops.

G-Supress DX Pediatric Drops is a product that's used for the temporary relief of common cold symptoms, as per the recall notice. On the other hand, Finafta, which Novis does not even manufacture, is an Anesthetic/Analgesic liquid for the relief of mouth irritations or inflammations.

The Finafta product also contains 60% ethyl alcohol and 5% benzocaine, both of which could have adverse health impacts. Products with alcohol are particularly hazardous for young children because of their higher risks for alcohol toxicity.

"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 noted. "Benzocaine can cause methemoglobinemia, a potentially life-threatening condition where too little oxygen is delivered to your cells."

So far, there have been no reports of adverse events related to the recall.

The issuance affects the "G-Supress DX Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant Cherry Flavor" with Lot D20911 and "Exp 10/25." These came in bottles in carton boxes and were distributed to pharmacies in Puerto Rico.

The company has already notified distributors and customers of the recall. The FDA, in its alert, also urged pharmacies not to sell the recalled lot anymore, and customers to not use them. Instead, they may return it to where they bought it.

Those with questions about the recall may contact the company at 787-767-2072, while customers who may have concerns or problems related to using the product are being advised to contact their healthcare provider.

Problems with the drug may also be reported to the FDA's MedWatch Adverse Event Reporting program online, or they may call 1- 800-332-1088 to request for the form, which they could then mail or send by fax to 1-800-FDA-0178.

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