FDA Drugs recall ·
Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz recall
- Recall number
- D-0139-2025
- Date
- (initiated November 14, 2024)
- Company / brand
- Keystone Industries
480 S Democrat Rd, Gibbstown, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Terminated
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-13119
Distribution
Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0139-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.