PlainRecalls
FDA Drug Moderate Class II Ongoing

M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co LL, 105-30 101 Avenue, Ozone Park, NY 11416.

Reported: December 25, 2024 Initiated: November 14, 2024 #D-0138-2025

Product Description

M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co LL, 105-30 101 Avenue, Ozone Park, NY 11416.

Reason for Recall

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.

Details

Recalling Firm
Keystone Industries
Distribution
Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Location
Gibbstown, NJ

Frequently Asked Questions

What product was recalled?
M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co LL, 105-30 101 Avenue, Ozone Park, NY 11416.. Recalled by Keystone Industries.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 25, 2024. Severity: Moderate. Recall number: D-0138-2025.