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
Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted). NDC # 0573-2161-14 SKU# F00573216114A (original lot # R73995) Co-packaged Batch/Lot # 0045DB, 9327VB, 0017DA & 9353WA
Lot numbers, UPCs & expiration codes
Batch/Lot # 0045DB, exp. date 07/31/2021, original lot # R73995 9327VB, exp. date 07/31/2021, original lot # R73995 0017DA, exp. date 07/31/2021, original lot # R73995 9353WA, exp. date 07/31/2021, original lot # R73995
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-1068-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 16, 2020
- FDA report date
- Apr 1, 2020
- Quantity
- 566 blister packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glaxosmithkline Consumer Healthcare Holdings
Original FDA data
Every field from FDA enforcement report D-1068-2020, 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 # 0045DB, exp. date 07/31/2021, original lot # R73995 9327VB, exp. date 07/31/2021, original lot # R73995 0017DA, exp. date 07/31/2021, original lot # R73995 9353WA, exp. date 07/31/2021, original lot # R73995
- Postal code
- 07059-6796
- Report date
- Apr 1, 2020
- Product type
- Drugs
- Recall number
- D-1068-2020
- Classification
- Class II
- Recalling firm
- Glaxosmithkline Consumer Healthcare Holdings
- Product quantity
- 566 blister packs
- 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
- Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted). NDC # 0573-2161-14 SKU# F00573216114A (original lot # R73995) Co-packaged Batch/Lot # 0045DB, 9327VB, 0017DA & 9353WA
- 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