Recalls / Class II
Class IID-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
- Brand name
- Advil Allergy And Congestion Relief
- Generic name
- Chlorpheniramine Maleate, Ibuprofen, And Phenylephrine Hydrochloride
- Active ingredients
- Chlorpheniramine Maleate, Ibuprofen, Phenylephrine Hydrochloride
- Route
- Oral
- NDCs
- 0573-2161, 0573-0196
- FDA application
- NDA022113
- Affected lot / code info
- 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
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
- Manufacturer
- Haleon US Holdings LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 184 Liberty Corner Rd, N/A, Warren, New Jersey 07059-6796
Distribution
- Quantity
- 471,024 blisters
- 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-1065-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.