D-1065-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 1, 2020
- Initiation Date
- March 16, 2020
- Termination Date
- October 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