Product: SORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin), 150 mg) in each 7.5 mL 1 1/2 tsp), GRAPE FLAVOR, 16 Fl.oz. (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR  00917, NDC 52083-660-16.
Reason for recall: CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Recall initiated: 20190621
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated