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
Reported: April 1, 2020 Initiated: March 16, 2020 #D-1065-2020
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.
Details
- Recalling Firm
- Glaxosmithkline Consumer Healthcare Holdings
- Units Affected
- 471,024 blisters
- Distribution
- Product was distributed throughout the United States, including Puerto Rico.
- Location
- Warren, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Glaxosmithkline Consumer Healthcare Holdings. Units affected: 471,024 blisters.
Why was this product recalled? ▼
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 1, 2020. Severity: Moderate. Recall number: D-1065-2020.
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