July 2022 FDA Recall Drug by The Procter & Gamble Company
D-1290-2022 - Labeling

This Class III drug recall was voluntarily initiated by The Procter & Gamble Company on July 8, 2022 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Washington State and the recall is currently completed.

Recall Number: D-1290-2022

Reason for Recall
Labeling: Missing label: the product tube was missing a label and contained a different formulation.
Initiated
07-08-2022
Reported
08-03-2022
Quantity
1,128 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90586
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The Procter & Gamble Company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Washington State
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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