Pharma-Natural Inc. recalls DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distrib
Recalled July 31, 2019 · FDA recall D-1498-2019 · 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
500 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
DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distributed by: Pamby Dist., Miami, FL 33414, NDC 63708-121-04.
Manufacturer(s)
Pharma-Natural Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →