FDAFDA · Food and drugs·Recall number D-1067-2020
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.)
Published April 1, 2020 · Recall initiated: March 16, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- INFANTS ADVIL
- Manufacturer
- Glaxosmithkline Consumer Healthcare Holdings
- Distributor
- Product was distributed throughout the United States, including Puerto Rico.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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