D-1497-2019 Class II Terminated
FDA drug recall D-1497-2019 was initiated by Pharma-Natural Inc. on Jun 21, 2019 and is designated Class II. Reason for recall: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations. The recall status is terminated (terminated Oct 27, 2021). Affected quantity: 3000 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 31, 2019
- Initiation Date
- Jun 21, 2019
- Termination Date
- Oct 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3000 bottles
Product Description
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.
Reason for Recall
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Distribution Pattern
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Code Information
All lots remaining within expiry.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1497-2019
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026