Glaxosmithkline Consumer Healthcare Holdings recalls Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20…

Recall date

March 16, 2020

Source

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

Recall number

D-1065-2020

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

Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tray in carton NDC 0573-0196-10, item # F00573019610C, 10 ct. blister NDC 0573-0196-20, item # F00573019620C, 20 ct. blister NDC 0573-0196-10, item # F00573019610R, 10 ct. blister