Sensodyne PRONAMEL
Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling: Missing label: the product tube was missing a label and contained a different formulation.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
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.
Drug: Fluoride
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now completed, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
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