Pharma-Natural Inc. recalls TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl, 10 mg) in each 5 mL tsp, Grape Flavor, 16

Recalled July 31, 2019 · FDA recall D-1504-2019 · 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

8340 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

TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl, 10 mg) in each 5 mL tsp, Grape Flavor, 16 Fl.oz. (474 mL) bottle, Kramer Novis, San Juan, PR 00917, NDC 52083-622-16.

Manufacturer(s)

Pharma-Natural Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →