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 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95
Lot numbers, UPCs & expiration codes
Batch/Lot Numbers: R53074, exp. date 10/31/2020, item # F00573176989, 160 ct. R53075, exp. date 10/31/2020, item # F00573176989, 160 ct. R53076, exp. date 11/30/2020, item # F00573176989, 160 ct. R53077, exp. date 11/30/2020, item # F00573176989, 160 ct. R53081, exp. date 11/30/2020, item # F00573176989, 160 ct. R53901, exp. date 02/28/2021, item # F00573176989, 160 ct. R53902, exp. date 03/31/2021, item # F00573176989, 160 ct. R62780, exp. date 06/30/2021, item # F00573176989, 160 ct.
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-1066-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 16, 2020
- FDA report date
- Apr 1, 2020
- Quantity
- 446,628 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glaxosmithkline Consumer Healthcare Holdings
Original FDA data
Every field from FDA enforcement report D-1066-2020, 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 Numbers: R53074, exp. date 10/31/2020, item # F00573176989, 160 ct. R53075, exp. date 10/31/2020, item # F00573176989, 160 ct. R53076, exp. date 11/30/2020, item # F00573176989, 160 ct. R53077, exp. date 11/30/2020, item # F00573176989, 160 ct. R53081, exp. date 11/30/2020, item # F00573176989, 160 ct. R53901, exp. date 02/28/2021, item # F00573176989, 160 ct. R53902, exp. date 03/31/2021, item # F00573176989, 160 ct. R62780, exp. date 06/30/2021, item # F00573176989, 160 ct.
- Postal code
- 07059-6796
- Report date
- Apr 1, 2020
- Product type
- Drugs
- Recall number
- D-1066-2020
- Classification
- Class II
- Recalling firm
- Glaxosmithkline Consumer Healthcare Holdings
- Product quantity
- 446,628 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 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1769-95
- 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