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Recall Observatory FDA recall evidence

Drug 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

D-1065-2020

March 16, 2020

Class II

Product summary

Firm
Glaxosmithkline Consumer Healthcare Holdings
Event
Event 85224
Status
Terminated
Classification
Class II
Quantity
471,024 blisters
Official record key
drug-enforcement:D-1065-2020

Official wording

Reason: Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

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

Distribution pattern: Product was distributed throughout the United States, including Puerto Rico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.