PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: February 19, 2020 Initiated: December 23, 2019 #D-0996-2020

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
GSK Consumer Health, Inc
Units Affected
431,614 cartons
Distribution
Distributed Nationwide in the USA
Location
Lincoln, NE

Frequently Asked Questions

What product 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. Recalled by GSK Consumer Health, Inc. Units affected: 431,614 cartons.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 19, 2020. Severity: Moderate. Recall number: D-0996-2020.