June 20, 2019
A typo on product label dosing instructions has prompted a Class I recall for 5766 bottles of Pecgen DMX Cough Suppressant Expectorant (NDC 52083-630-16), according to the June 19, 2019, US Food and Drug Administration (FDA) Enforcement Report. Instead of advising one teaspoon every 4 hours for children age 6 to under 12, the label incorrectly states “for children 6 to under 2 years of age.”
“Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age,” the FDA reported.
The recall is for Pecgen DMX Cough Suppressant Expectorant (contains the same active ingredients as Trispec DMX), sugar free, alcohol free, dye free, gluten free, cherry raspberry flavor, 16 fl. oz. (474 mL), from lots D80202 and D80210 (Exp. 2/20), D80818 and D80819 (Exp. 9/20), and D80820 (Exp. 9/20). The affected medication was distributed in Puerto Rico.
Novis PR Inc. voluntarily initiated the recall May 28, 2019. The FDA issued a Class I designation June 19, 2019, warning use of the affected product could cause serious adverse health consequences or death.
Pecgen DMX, which contains dextromethorphan hydrobromide and guaifenesin, is available over the counter as a cough suppressant and expectorant.