DENBLAN Anticavity Fluoride Toothpaste…

Date

July 30, 2014

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Terminated

Filed by

Estee Lauder Inc

Product

DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6 oz/75 mL tube, Laboratories Darphin, Dist, Paris France

Reason

Stability Data Does Not Support Expiry

Distribution pattern

Nationwide

Quantity

3,791 tubes

Codes and lots

All lot codes and shipment dates are being recalled. 2.6oz/75ml. in a light green carton, UPC: 8-82381-07901-7 Code: D079-01-1000

Recall started

June 6, 2014

Recall number

D-1452-2014

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-1452-2014. The agency record governs; check it and the company before acting.