Keystone Industries — Federal Records

FDA Drug Recall: Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufac 2024-12-25

Class II — CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was t...

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FDA Drug Recall: Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 2024-12-25

Class II — CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was t...

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FDA Drug Recall: Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Cont 2024-12-25

Class II — CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was t...

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FDA Drug Recall: safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz ( 2024-12-25

Class II — CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was t...

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FDA Drug Recall: Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), 2024-12-25

Class II — CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was t...

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FDA Drug Recall: Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 2024-12-25

Class II — CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was t...

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FDA Drug Recall: Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten 2024-12-25

Class II — CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was t...

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FDA Drug Recall: Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use On 2024-12-25

Class II — CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was t...

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FDA Drug Recall: M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. 2024-12-25

Class II — CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was t...

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FDA Drug Recall: Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada. 2024-12-25

Class II — CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was t...

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FDA Drug Recall: Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), 2024-12-25

Class II — CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was t...

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FDA Drug Recall: Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), 2024-12-25

Class II — CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was t...

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FDA Drug Recall: Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, 2024-11-20

Class II — Subpotent Drug

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FDA Device Recall: KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental 2024-01-10

Class II — Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint...

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FDA Device Recall: Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a m 2023-09-20

Class II — A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).

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FDA Device Recall: Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining M 2023-09-20

Class II — The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0717) (0921250HS) on the outer box. The contents of the Kit and the IFU enclosed...

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