# FDA recall D-1068-2020

> **Glaxosmithkline Consumer Healthcare Holdings** · Class II · drug recall initiated 2020-03-16.

## Product

Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted).   NDC # 0573-2161-14  SKU# F00573216114A (original lot # R73995)  Co-packaged Batch/Lot # 0045DB, 9327VB, 0017DA & 9353WA

## Reason for recall

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

## Distribution

Product was distributed throughout the United States, including Puerto Rico.

## Key facts

- **Recall number:** D-1068-2020
- **Recalling firm:** Glaxosmithkline Consumer Healthcare Holdings
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-03-16
- **Report date:** 2020-04-01
- **Termination date:** 2021-10-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warren, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1068-2020

## Citation

> AI Analytics. FDA recall D-1068-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1068-2020. Source: US FDA. Licensed CC0.

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