Recalls / Class II
Class IID-1069-2020
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
- Affected lot / code info
- Batch/Lot # Lot # 0198FR, original lot # R53074, exp. date 10/31/2020 Lot # 3188FRB, original lot # R53074, exp. date 10/31/2020
Why it was recalled
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Recalling firm
- Firm
- Glaxosmithkline Consumer Healthcare Holdings
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 184 Liberty Corner Rd, N/A, Warren, New Jersey 07059-6796
Distribution
- Quantity
- 4,104 bottles
- Distribution pattern
- Product was distributed throughout the United States, including Puerto Rico.
Timeline
- Recall initiated
- 2020-03-16
- FDA classified
- 2020-03-26
- Posted by FDA
- 2020-04-01
- Terminated
- 2021-10-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1069-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.