Keystone Industries is recalling various brands of 20% Benzocaine Topical Anesthetic Gels, including Gelato, Benzo-Jel, SensiCaine Ultra, and others, because the bulk product was prepared in a mixing vessel that had scratches on the bottom and sides. Although the quality unit initially rejected the product due to these manufacturing deviations, it was inadvertently shipped to customers across the United States and internationally. These gels are used professionally and over-the-counter to numb oral tissues for dental procedures or pain relief.
The scratches in the manufacturing equipment indicate that the lining of the mixing vessel may have compromised the product, potentially introducing physical contaminants or metal fragments. Applying contaminated gel to sensitive oral tissues could cause irritation, injury, or other adverse health effects.
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Sources: FDA iRES · Raw API Response
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