Keystone Industries recalls Primo topical anesthetic gel (Benzocaine 20%) due to CGMP deviations during manufacturing. The product was rejected but shipped after routine inspection found scratches in the mixing vessel.
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.
Keystone Industries is recalling Primo topical anesthetic gel (Benzocaine 20%) because it was shipped after being rejected for scratches in the mixing vessel. This could lead to contamination risks during production.
The product was rejected by quality control due to scratches in the mixing vessel. These scratches could allow contaminants to enter the product during manufacturing, potentially causing contamination.
People who own or use Primo topical anesthetic gel (Benzocaine 20%) with lot number BNZ-001646 are affected. Dental professionals and patients using the product are most at risk.
Check for lot number BNZ-001646 on the product label. The product is manufactured by Keystone Industries for Primo Dental, with a net content of 1 oz. (30g).
Look for lot number BNZ-001646 on the product label to confirm if it is recalled.
The product was rejected by quality control due to scratches in the mixing vessel, but it was shipped after being inadvertently released. The official notice does not state if it is safe to use.
The official recall notice does not mention any replacement or remedy steps.
The official recall notice does not specify a remedy, so contact Keystone Industries directly for guidance.
We’ve drafted a message you can send Keystone Industries to request your refund or repair — edit it as you like.
Subject: Recall D-0139-2025 — Keystone Industries Keystone Industries Hello, I own a Keystone Industries that is covered by recall D-0139-2025 from Keystone Industries. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
