Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported June 19, 2019
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.
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 st…
Novis Pr, Inc. recalled Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredients as Trispec… - a critical-severity action.
Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredients as Trispec… was recalled by Novis Pr, Inc. in June 19, 2019. Reason: Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its l…. Check the official notice for the remedy. Verify recall #D-1395-2019 with the FDA Drug before acting.
The recall
Novis Pr, Inc. issued this critical-severity FDA Drug recall-Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its l….
- Critical
- severity level
- Class I
- classification
- June 19, 2019
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1395-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1395-2019) was formally reported on June 19, 2019, with the manufacturer initiating the action on May 28, 2019. It is classified under Critical severity (Class I), with a current status of Terminated. Novis Pr, Inc. is listed as the recalling firm, operating out of San Juan, PR. Federal records list the affected scope as 5766 bottles.
The documented reason for this recall is: 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,… Distribution data in the federal record shows the product reached: Puerto Rico. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,436 drugs & medications recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
5766 bottles
Related Recalls
6
6 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-1395-2019 |
| Date reported | June 19, 2019 |
| Date initiated | May 28, 2019 |
| Recalling firm | Novis Pr, Inc. |
| Firm location | San Juan, PR |
| Affected scope | 5766 bottles |
| Distribution | Puerto Rico |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1395-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product 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.. Recalled by Novis Pr, Inc.. Units affected: 5766 bottles.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Drug on June 19, 2019. Severity: Critical. Recall number: D-1395-2019.
Where was the recalled product distributed? ▼
Distribution: Puerto Rico.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1395-2019) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nationwide recalls with similar severity or category timing
Two federal-filing-derived peer sets for this notice, both outside the same recalling firm and filing state so the neighborhoods are not firm or geographic containment.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Drugs & Medications · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported June 19, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.