DOUBLE TUSSIN DM in each teaspoon 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 DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distri…

Recall number

D-1498-2019

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

DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distributed by: Pamby Dist., Miami, FL 33414, NDC 63708-121-04.