Novis PR, Inc. is recalling approximately 5,766 bottles of Pecgen DMX Cough Suppressant Expectorant (guaifenesin, dextromethorphan, and phenylephrine) because the drug facts label contains a typographical error regarding dosage. The label incorrectly provides dosage instructions for children as young as 6 months to under 2 years of age, when it was intended for children ages 6 to under 12. This error could lead to young children receiving an incorrect and potentially dangerous amount of the medication. The 16-ounce bottles were distributed throughout Puerto Rico.
Caregivers following the incorrect label may provide an adult-strength dosage to infants and toddlers as young as 6 months old. This creates a high risk of accidental overdose, which can lead to serious adverse health effects in young children, especially since the label also fails to advise consulting a doctor for children under 2 years of age.
Pharmacy refund
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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