# FDA recall D-0996-2020

> **GSK Consumer Health, Inc** · Class II · drug recall initiated 2019-12-23.

## Product

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.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0996-2020
- **Recalling firm:** GSK Consumer Health, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-12-23
- **Report date:** 2020-02-19
- **Termination date:** 2023-03-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lincoln, NE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0996-2020

## Citation

> AI Analytics. FDA recall D-0996-2020. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/D-0996-2020. Source: US FDA. Licensed CC0.

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