Pharma-Natural Inc. recalls NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavo
Recalled July 31, 2019 · FDA recall D-1506-2019 · 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
2052 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
NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavor, 16 fl oz (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-699-16.
Manufacturer(s)
Pharma-Natural Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →