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Recall Observatory FDA recall evidence

Drug product

Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with $1 IRC (mixed product display - only Advil Allergy & Congestion is impacted). NDC # 0573-2161-14 SKU# F00573216114A (original lot # R73995) Co-packaged Batch/Lot # 0045DB, 9327VB, 0017DA & 9353WA

D-1068-2020

March 16, 2020

Class II

Product summary

Firm
Glaxosmithkline Consumer Healthcare Holdings
Event
Event 85224
Status
Terminated
Classification
Class II
Quantity
566 blister packs
Official record key
drug-enforcement:D-1068-2020

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 # 0045DB, exp. date 07/31/2021, original lot # R73995 9327VB, exp. date 07/31/2021, original lot # R73995 0017DA, exp. date 07/31/2021, original lot # R73995 9353WA, exp. date 07/31/2021, original lot # R73995

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.