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
Check against the official notice below — it lists the full affected range.
Glaxosmithkline Consumer Healthcare is recalling Advil Allergy & Congestion Relief tablets containing 200 mg ibuprofen, 4 mg chlorpheniramine maleate, and 10 mg phenylephrine in 10 and 20 count blister packages. Certain lots of this product lack required safety warning information in the Drug Facts Panel on the label. The affected lots are: R73995 (expiration 07/31/2021), R53915 (expiration 05/31/2020), 9324HA (expiration 07/31/2021), and 9327HA (expiration 07/31/2021). A total of 471,024 blisters were distributed throughout the United States, including Puerto Rico.
The missing warning information on the label could prevent consumers from being aware of important safety considerations before taking this medication. The source document does not specify a remedy or what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
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. Quantity: 471,024 blisters Lot/code info: Batch/Lot Numbers: R73995, exp. date 07/31/2021 R53915, exp. date 05/31/2020 9324HA, exp. date 07/31/2021 9327HA, exp. date 07/31/2021
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.