TOPIC: G-Supress DX Pediatric Drops by Novis PR: Recall - Due to Incorrect Packaging
AUDIENCE: Consumer, Patient, Health Professional, Pharmacy, Pediatrics, Family Practice
ISSUE: Novis PR is recalling Lot D20911 Exp 10/25 of G-Supress DX Pediatric Drops because 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.
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. Lot D20911 was distributed among pharmacies in Puerto Rico.
To date, Novis PR has not receive any reports of adverse events or injuries related to this recall.
For more information about this recall click on the red button "Read Recall" below.
BACKGROUND: G-Supress DX Pediatric Drops is a cough suppressant, expectorant and nasal decongestant used for the temporary relief of common cold symptoms. Oral anesthetic/analgesic liquid is used for temporary pain relief for the mouth and gums.
RECOMMENDATIONS:
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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.
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Consumers/distributors/retailers that have affected lot should stop using and return to place of purchase.
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Consumers with questions regarding this recall can contact the company.
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