Pharma-Natural Inc. recalls SORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin), 150 mg) in each 7.5 mL 1 1/2 tsp), GRAPE F
Recalled July 31, 2019 · FDA recall D-1505-2019 · 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
7392 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
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.
Manufacturer(s)
Pharma-Natural Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →