Key Takeaway
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), Manufactur by Novis PR, Inc. was recalled on May 28, 2019. The hazard: Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The dr...
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), Manufactur
Description
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), Manufactured in the USA for Kramer Novis, San Juan, PR 00917, www.kramernovis.com, NDC 52083-630-16.
Hazard / Reason
Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.
Class I: Dangerous or defective product that could cause serious health problems or death.
Class I is the most serious recall classification used by the FDA, indicating a reasonable probability of serious health consequences or death.
Products Affected
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), Manufactur
DrugsCompany Information
Novis PR, Inc.
San Juan, PR, United States
View all 1 recalls by Novis PR, Inc. →Distribution
Puerto Rico
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Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
Check the remedy section above or contact the manufacturer directly for current remedy options.
Where can I find the original recall notice?
This recall was issued by FDA Drug. Visit the agency's official website for the original notice.