Drug product
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
D-1068-2020
Product summary
- Event
- Event 85224
- Status
- Terminated
- Classification
- Class II
- Quantity
- 566 blister packs
- Official record key
drug-enforcement:D-1068-2020
Official wording
Reason: Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
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
Distribution pattern: Product was distributed throughout the United States, including Puerto Rico.
Derived failure modes
-
Unknown
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.