Pecgen DMX Cough Suppressant Expectorant — Class I drug recall D-1395-2019
Terminated recall by Novis PR, Inc., reported 2019-06-19, distributed in PR. Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its la
| Recall number | D-1395-2019 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novis PR, Inc., San Juan, PR, United States |
| Recall initiated | 2019-05-28 |
| Classified | 2019-06-19 |
| Reported by FDA | 2019-06-19 |
| Terminated | 2021-02-10 |
| Distributed | PR |
| Quantity | 5,766 bottles |
| Reason classes | labeling |
| NDC | 52083-0630, 52083-0630-16 |
| Lot numbers | 02/20, 09/20, D80202, D80210, D80818, D80819, D80820 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1395-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.