D-1068-2020 Class II Terminated
FDA drug recall D-1068-2020 was initiated by Glaxosmithkline Consumer Healthcare Holdings on Mar 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 Oct 28, 2021). Affected quantity: 566 blister packs.
Recall details
- Product Type
- Drugs
- Report Date
- Apr 1, 2020
- Initiation Date
- Mar 16, 2020
- Termination Date
- Oct 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 566 blister packs
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
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 # 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1068-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026