TUSSLIN in each tsp recalled over manufacturing violations

Recall date

June 21, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

D-1504-2019

FDA classification

Class II

Brand / firm

Pharma-Natural Inc.

Sold / distributed

Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.