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Recall Observatory FDA recall evidence

Drug product

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

D-1452-2014

June 06, 2014

Class III

Product summary

Firm
Estee Lauder Inc
Event
Event 68449
Status
Terminated
Classification
Class III
Quantity
3,791 tubes
Official record key
drug-enforcement:D-1452-2014

Official wording

Reason: Stability Data Does Not Support Expiry

Code information: 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

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Stability Data Does Not Support Expiry