Sogeval Laboratories Inc. is recalling 21,259 units of Ketoseb Flush+PS (Chlorhexidine 2%, Ketoconazole 0.2%, Phytosphingosine 0.02%) 16 FL OZ bottles due to a labeling error. The product label incorrectly states the concentration of the active ingredient Chlorhexidine as 2%, when the actual concentration is significantly lower at 0.2%. This antiseptic formulation for pets was distributed to eight domestic distributors and one foreign distributor in Canada prior to April 17, 2013.
The incorrect labeling means the product provides only one-tenth of the antiseptic concentration expected by the user. This reduced strength may lead to ineffective treatment of the pet's skin condition, potentially allowing infections or irritations to persist or worsen.
Veterinary drug recall remedy
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Sources: FDA iRES · Raw API Response