Glaxosmithkline Consumer Healthcare Holdings: Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-01

Is my product affected?

Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bottles NDC 0573-0191-75 (0.75 oz.) NDC 0573-0191-50 (1 oz.)

• Brand INFANTS ADVIL

Check against the official notice below — it lists the full affected range.

What happened

GlaxoSmithKline Consumer Healthcare is recalling Advil Infant Concentrated Drops (ibuprofen 50 mg per 1.25 mL oral suspension) in white grape flavor because certain lots lack required safety warning information in the Drug Facts Panel on the label. A total of 151,056 bottles were distributed throughout the United States, including Puerto Rico. The affected products include 0.75 oz. and 1 oz. bottles with specific lot numbers and expiration dates ranging from March 2020 through November 2021.

The affected lot numbers are: R73761 (0.75 oz., expires 01/31/2021), R74936 (0.75 oz., expires 02/28/2021), R56290 (1 oz., expires 03/31/2020), R60959 (1 oz., expires 02/28/2021), R78826 (1 oz., expires 11/30/2021), 9335UA (0.75 oz. co-package, expires 01/31/2021), and 9336UA (0.75 oz. co-package, expires 02/28/2021). The source document does not specify what action consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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: 151,056 bottles Lot/code info: Batch/Lot # R73761, exp. date 01/31/2021, Item # F00573019175, 0.75 oz. R74936, exp. date 02/28/2021, Item # F00573019175, 0.75 oz. R56290, exp. date 03/31/2020, Item # F00573019150, 1 oz. R60959, exp. date 02/28/2021, Item # F00573019150, 1 oz. R78826, exp. date 11/30/2021, Item # F00573019150, 1 oz. 9335UA, exp. date 01/31/2021, item # F00573019175A - Co-package 9336UA, exp. date 02/28/2021, item # F00573019175A - Co-package

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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