Glaxosmithkline Consumer Healthcare Holdings recalls Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advi…

Recall date

March 16, 2020

Source

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

Recall number

D-1068-2020

FDA classification

Class II

Brand / firm

Glaxosmithkline Consumer Healthcare Holdings

Sold / distributed

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

Why it was recalled

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

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

What 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