Pharma-Natural Inc. recalls GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL tsp, Cherr
Recalled July 31, 2019 · FDA recall D-1497-2019 · Pharma-Natural
Hazard
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations. · FDA Class II
Units
3000 bottles
Sold at
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Description
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
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.
Manufacturer(s)
Pharma-Natural Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →