CLASS II Drug recall · Reported 31 Jul 2019 · FDA Enforcement Report
Gencontuss (Chlorpheniramine Maleate, 2mg recalled by Pharma-Natural
Pharma-Natural is recalling Gencontuss (Chlorpheniramine Maleate, 2mg, distributed nationwide in the US. The recall was initiated on 21 Jun 2019 and the FDA has classified it as Class II.
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-1497-2019
- FDA event ID
- 83190
- Recalling firm
- Pharma-Natural, Miami Lakes, FL
- Brand
- Gencontuss
- Manufacturer
- KRAMER NOVIS
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jun 2019
- FDA classified
- 23 Jul 2019
- Reported
- 31 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Allergy Medication
Timeline
| 21 Jun 2019 | Recall initiated by company | |
| 23 Jul 2019 | Classified by FDA | +32 days |
| 31 Jul 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL tsp, Cherry Flavor, 16 fl oz (474 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-650-16.
Where it was distributed
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Questions about this recall
Why was it recalled?
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Which lots are affected?
All lots remaining within expiry.
Where was it sold?
Consignees in FL and TX who may have further distributed Nationwide in the USA and 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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
15 other products · FDA event 83190More recalls from Pharma-Natural
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS III | Pharma Natural, Biotin 5000 mcg, Maximum Strength recalledPharma | Pharma-Natural | Other | PR |
| Drug | CLASS II | Army Health With Curcumin (Menthol 3.00%) Pain Reliever recalled | Pharma-Natural | Potency & Assay | Nationwide |
| Drug | CLASS II | Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief recalled | Pharma-Natural | Potency & Assay | Nationwide |
| Drug | CLASS II | Dermanak original crema blanqueador recalled by Pharma-Natural | Pharma-Natural | Potency & Assay | Nationwide |
| Drug | CLASS II | Neogen-d (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg recalled | Pharma-Natural | Potency & Assay | Nationwide |
Other Chlorpheniramine recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Chlorpheniramine Maleate recalled by BLI InternationalChlorpheniramine Maleate 4mg | BLI International | Potency & Assay | MO |
| Drug | CLASS II | Chlorpheniramine/Hyoscyamine 10MG/0.25MG/ML Injectable recalled | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Nohist-dm Antihistamine/Antitussive Nasal Decongestant recalledNohist Dm | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine recalledAdvil Allergy And Congestion Relief | Glaxosmithkline Consumer Healthcare Holdings | Other | Nationwide |
| Drug | CLASS II | Chlorpheniramine Maleate 10 mg/ml MDV, Rx recalled by Pharmacy Plus | Pharmacy Plus | Sterility | MS |