Recalls / Class II
Class IID-1497-2019
Product
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.
- Brand name
- Gencontuss
- Generic name
- Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
- Active ingredients
- Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
- Route
- Oral
- NDC
- 52083-650
- FDA application
- M012
- Affected lot / code info
- All lots remaining within expiry.
Why it was recalled
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Recalling firm
- Firm
- Pharma-Natural Inc.
- Manufacturer
- KRAMER NOVIS
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 14500 Nw 60th Ave Bldg 7f, N/A, Miami Lakes, Florida 33014
Distribution
- Quantity
- 3000 bottles
- Distribution pattern
- Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2019-06-21
- FDA classified
- 2019-07-23
- Posted by FDA
- 2019-07-31
- Terminated
- 2021-10-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1497-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.