WhichRecall
Class IIReported 2024-12-25

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.

Recalled by Keystone Industries

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

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

Recall Number
D-0139-2025
Classification
Class II
Status
Completed
Category
drug
Initiated
2024-11-14
Reported
2024-12-25
Distribution
Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Code Info
Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-13119
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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