PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: April 1, 2020 Initiated: March 16, 2020 #D-1068-2020

Product Description

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.

Details

Units Affected
566 blister packs
Distribution
Product was distributed throughout the United States, including Puerto Rico.
Location
Warren, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Glaxosmithkline Consumer Healthcare Holdings. Units affected: 566 blister packs.
Why was this product recalled?
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 1, 2020. Severity: Moderate. Recall number: D-1068-2020.