D-1065-2020 Class II Terminated
FDA drug recall D-1065-2020 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: 471,024 blisters.
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
- 471,024 blisters
Product description
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tray in carton NDC 0573-0196-10, item # F00573019610C, 10 ct. blister NDC 0573-0196-20, item # F00573019620C, 20 ct. blister NDC 0573-0196-10, item # F00573019610R, 10 ct. blister
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 Numbers: R73995, exp. date 07/31/2021 R53915, exp. date 05/31/2020 9324HA, exp. date 07/31/2021 9327HA, exp. date 07/31/2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1065-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026