FDA Drug Recalls

Recalls / Class III

Class IIID-1290-2022

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.

Affected lot / code info
Lot: a) 13191707B4, Exp. 10/31/2023; b)13511707Y1, Exp. 10/31/2023.

Why it was recalled

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

Recalling firm

Firm
The Procter & Gamble Company
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
1 Procter And Gamble Plz, Cincinnati, Ohio 45202-3315

Distribution

Quantity
1,128 tubes
Distribution pattern
Washington State

Timeline

Recall initiated
2022-07-08
FDA classified
2022-07-26
Posted by FDA
2022-08-03
Status
Completed

Source: openFDA Drug Enforcement endpoint. Recall record D-1290-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.