# FDA recall D-1395-2019

> **Novis PR, Inc.** · Class I · drug recall initiated 2019-05-28.

## Product

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.

## Reason for recall

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.

## Distribution

Puerto Rico

## Key facts

- **Recall number:** D-1395-2019
- **Recalling firm:** Novis PR, Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-05-28
- **Report date:** 2019-06-19
- **Termination date:** 2021-02-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Juan, PR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1395-2019

## Citation

> AI Analytics. FDA recall D-1395-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1395-2019. Source: US FDA. Licensed CC0.

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