CLASS I Drug recall · Reported 19 Jun 2019 · FDA Enforcement Report
Pecgen DMX Cough Suppressant Expectorant recalled by Novis PR
Novis PR is recalling Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredients as Trispec, distributed in Puerto Rico. The recall was initiated on 28 May 2019 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1395-2019
- FDA event ID
- 82968
- Recalling firm
- Novis PR, San Juan, PR
- Brand
- Pecgen Dmx
- Manufacturer
- KRAMER NOVIS
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 28 May 2019
- FDA classified
- 19 Jun 2019
- Reported
- 19 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Drug class
- Cold & Cough Medicine
Timeline
| 28 May 2019 | Recall initiated by company | |
| 19 Jun 2019 | Classified by FDA | +22 days |
| 19 Jun 2019 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Puerto Rico
Questions about this recall
Why was it 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.
Which lots are affected?
Lot #s: D80202, D80210 Exp. 02/20; D80818, D80819 Exp. 09/20; D80820 Exp. 09/20
Where was it sold?
Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Novis PR
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|---|---|---|---|---|---|
| Drug | CLASS I | G-Supress DX (Dextromethorphan HBr, Guaifenesin recalled by Novis PRG-supress Dx | Novis PR | Packaging Defects | PR |
| Food | CLASS II | PreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt recalledPreProtein | Novis PR | Other | PR |
| Food | CLASS II | PreProtein, Liquid Predigested Protein, Dietary Supplement recalledPreProtein | Novis PR | Other | PR |
| Food | CLASS II | GPre Protein, Liquid predigested Protein recalled by Novis PRGPre | Novis PR | Foreign Material | PR |
| Food | CLASS III | G-preprotein, Liquid Predigested Protein recalled by Novis PR | Novis PR | Other | PR |
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|---|---|---|---|---|---|
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| Drug | CLASS III | Adult Cough and Chest Congestion recalled by Denison PharmaceuticalsMaximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo Pack | Denison Pharmaceuticals | Packaging Defects | RI |
| Drug | CLASS II | Rompe Pecho DM recalled by Efficient LaboratoriesRompe Pecho | Efficient Laboratories | Sterility | Nationwide |
| Drug | CLASS II | Rompe Pecho CF Cold & Flu Advanced Formula recalledRompe Pecho | Efficient Laboratories | Sterility | Nationwide |
| Drug | CLASS II | Childrens Robitussin Honey Cough and Chest Congestion DM recalledChildrens Robitussin Honey Cough And Chest Congestion Dm | Glaxosmithkline Consumer Healthcare Holdings | Other | Nationwide |