Pecgen DMX Cough Suppressant Expectorant (Dextromethorphan Hbr, Guaifenesin)

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

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.

Cause type: Labeling / mix-up

Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.

What was recalled

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.

Affected NDC 52083-0630-16

Compare with the code on your package — it is the most precise check available.

Drug: Alcohol

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

Product	Strength	Form & route	Labeler	Type
Pecgen Dmx Dextromethorphan HBr, Guaifenesin NDC 52083-0630	DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL; GUAIFENESIN 187 mg/5mL	Solution Oral	Kramer Novis	OTC

Recalling firm: Novis PR, Inc.
NDC code: 52083-630-16
Origin: PR, United States
Initiated by: Voluntary: Firm initiated
FDA recall number: D-1395-2019 · FDA notice

Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.