drugs Class II Updated 2024-12-25

Keystone Industries recalls Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content:

Recalled Product

Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th Floor, New York, NY 10022.

Hazard / Issue

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 to be rejected but was inadvertently released and shipped to customers.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-13119
View official government recall

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