Novis PR, Inc. Recalls | Public Health Trace

No ongoing recalls currently shown

Based on the official records currently available to Public Health Trace, no recalls naming Novis PR, Inc. are currently shown as ongoing. The 1 record below is a historical recall record.

Public Health Trace has 1 recall naming Novis PR, Inc. as the recalling firm, republished from official FDA and USDA sources.

Recall history - 1 terminated record

Recalls by year

Recalls by year
Year	Recalls
2019	1

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FDA Recall TerminatedTerminated: February 10, 2021Historical recordClass I

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.

by Novis PR, Inc.

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.
Published: June 19, 2019
Distribution: Puerto Rico

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Some FDA recall records on this page come from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

This page lists recalls that name Novis PR, Inc. as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.