D-1069-2020 Class II Terminated
FDA drug recall D-1069-2020 was initiated by Glaxosmithkline Consumer Healthcare Holdings on March 16, 2020 and is designated Class II. Reason for recall: Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. The recall status is terminated (terminated October 28, 2021). Affected quantity: 4,104 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 1, 2020
- Initiation Date
- March 16, 2020
- Termination Date
- October 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,104 bottles
Product Description
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
Reason for Recall
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Distribution Pattern
Product was distributed throughout the United States, including Puerto Rico.
Code Information
Batch/Lot # Lot # 0198FR, original lot # R53074, exp. date 10/31/2020 Lot # 3188FRB, original lot # R53074, exp. date 10/31/2020