Drug recall D-1065-2020
Product
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.
Lots and codes
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
Recall details
- Recalling firm
- Glaxosmithkline Consumer Healthcare Holdings, Warren, NJ
- Quantity
- 471,024 blisters
- Distribution
- Product was distributed throughout the United States, including Puerto Rico.
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 16, 2020
- Terminated
- October 28, 2021
Related products
- Advil Allergy and Congestion Relief – drug information
- NDC 0573-2161 Advil Allergy and Congestion Relief · Chlorpheniramine Maleate 4 mg/1; Ibuprofen 200 mg/1;… · Haleon US Holdings LLC
- NDC 0573-0196 Advil Allergy and Congestion Relief · Chlorpheniramine Maleate 4 mg/1; Ibuprofen 200 mg/1;… · Haleon US Holdings LLC