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 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 ct. blister
Lot numbers, UPCs & expiration codes
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
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-1065-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 16, 2020
- FDA report date
- Apr 1, 2020
- Quantity
- 471,024 blisters
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glaxosmithkline Consumer Healthcare Holdings
Original FDA data
Every field from FDA enforcement report D-1065-2020, 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: R73995, exp. date 07/31/2021 R53915, exp. date 05/31/2020 9324HA, exp. date 07/31/2021 9327HA, exp. date 07/31/2021
- Postal code
- 07059-6796
- Report date
- Apr 1, 2020
- Product type
- Drugs
- Recall number
- D-1065-2020
- Classification
- Class II
- Recalling firm
- Glaxosmithkline Consumer Healthcare Holdings
- Product quantity
- 471,024 blisters
- 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 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 ct. blister
- 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