FDA Drug recall D-1497-2019
GENCONTUSS (Chlorpheniramine Maleate, 2mg
- FDA Drug
- Class II
- terminated
- Published 2019-07-31
On 2019-07-31 the FDA classified a Class II recall of GENCONTUSS (Chlorpheniramine Maleate, 2mg by Pharma Natural, citing CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1497-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-21 |
| Published | 2019-07-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pharma Natural |
| Distribution | US |
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.
Reason
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Identifiers
| ndc | 52083-650-16 |
|---|---|
| code_info | All lots remaining within expiry. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1497-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.