Keystone Industries recalls Safco SensiCaine Ultra topical anesthetic gel (1 oz cherry) due to CGMP deviations from mixing vessel scratches. Product was inadvertently released after routine inspection.
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 has recalled Safco SensiCaine Ultra topical anesthetic gel (1 oz cherry) because manufacturing defects in the mixing vessel led to product being shipped despite being rejected. This affects dental professionals using the product for professional procedures.
The product was rejected by quality control due to scratches on the mixing vessel but was inadvertently shipped. This manufacturing defect could lead to inconsistent product quality, though the specific risk to users is not clearly described in the recall notice.
Dental professionals who use Safco SensiCaine Ultra topical anesthetic gel for professional procedures are affected. The risk is highest for those using the product during dental treatments.
Check for the product name 'SensiCaine Ultra', 1 oz (29.6 mL) cherry flavor, NDC 67239-0219-1, and lot number BNZ-001646. The product was distributed by Safco Dental Supply Co. in the U.S. for professional use only.
Verify the product name, size, flavor, NDC code, and lot number to confirm if it's affected.
The product was rejected by quality control due to scratches on the mixing vessel but was inadvertently shipped after routine inspection.
The recall notice does not specify a remedy.
This product is intended for professional use only by dental professionals.
We’ve drafted a message you can send Keystone Industries to request your refund or repair — edit it as you like.
Subject: Recall D-0145-2025 — Keystone Industries Keystone Industries Hello, I own a Keystone Industries that is covered by recall D-0145-2025 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.
