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Recall Observatory FDA recall evidence

Drug product

Crest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.243% sodium fluoride, Net Wt. 5.6 oz (158 g) a) Individual carton, UPC 0 37000 598534; b) 5-count Bundle, UPC 037000171867, Distributed. By Procter & Gamble, Cincinnati, OH 45202.

D-1290-2022

July 08, 2022

Class III

Product summary

Firm
The Procter & Gamble Company
Event
Event 90586
Status
Completed
Classification
Class III
Quantity
1,128 tubes
Official record key
drug-enforcement:D-1290-2022

Official wording

Reason: Labeling: Missing label: the product tube was missing a label and contained a different formulation.

Code information: Lot: a) 13191707B4, Exp. 10/31/2023; b)13511707Y1, Exp. 10/31/2023.

Distribution pattern: Washington State

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Missing