Drug product
Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F00573171559 (original lot # R53074) Co-packaged Batch/Lot # 0198FR & 3188FRB
D-1069-2020
Product summary
- Event
- Event 85224
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,104 bottles
- Official record key
drug-enforcement:D-1069-2020
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 # Lot # 0198FR, original lot # R53074, exp. date 10/31/2020 Lot # 3188FRB, original lot # R53074, exp. date 10/31/2020
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.