GSK Consumer Health, Inc recalls Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton. Distributed by: GSK Consumer Healthca…

Recall date

December 23, 2019

Source

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

Recall number

D-0996-2020

FDA classification

Class II

Brand / firm

GSK Consumer Health, Inc

Sold / distributed

Distributed Nationwide in the USA

Why it was recalled

Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the product label, Ask a doctor before use if you have a sodium-restricted diet.

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

What was recalled

Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059. NDC carton: 0067-6089-01, NDC packet: 0067-6089-03