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.

Recall Number: D-1504-2019

Firm: Pharma-Natural Inc.

Classification: Class II

Status: Terminated

Report Date: 20190731

Initiation Date: 20190621

Termination Date: 20211027

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

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.