Why it was recalled
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Product description
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.)
Lot numbers, UPCs & expiration codes
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
Where it was sold
Product was distributed throughout the United States, including Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1067-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 16, 2020
- FDA report date
- Apr 1, 2020
- Quantity
- 151,056 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glaxosmithkline Consumer Healthcare Holdings
Original FDA data
Every field from FDA enforcement report D-1067-2020, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 85224
- Address
- 184 Liberty Corner Rd
- Code information
- 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
- Postal code
- 07059-6796
- Report date
- Apr 1, 2020
- Product type
- Drugs
- Recall number
- D-1067-2020
- Classification
- Class II
- Recalling firm
- Glaxosmithkline Consumer Healthcare Holdings
- Product quantity
- 151,056 bottles
- Termination date
- Oct 28, 2021
- Reason for recall
- Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.)
- Distribution pattern
- Product was distributed throughout the United States, including Puerto Rico.
- Recall initiation date
- Mar 16, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 26, 2020