Keystone Industries recalls Health-Tec topical anesthetic gel due to CGMP deviations where mixing vessel scratches were found during routine inspection, leading to product release.
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 Health-Tec topical anesthetic gel (Benzocaine 20%) because quality control failed to catch scratches in the mixing vessel before shipping. This could mean the product was contaminated or not properly manufactured, though no injuries have been reported.
The mixing vessel had scratches during routine inspection, which could have led to contamination or improper manufacturing. The product was released to customers despite being rejected by quality control, but no injuries have been reported.
People who own or use Health-Tec topical anesthetic gel (Benzocaine 20%) made in the USA, 1 fl. oz. with NDC 69634-021-30 are affected. Those with sensitive skin or medical conditions using the product are at slightly higher risk.
Check for the product name 'Health-Tec Topical Anesthetic Gel', Benzocaine 20%, 1 fl. oz. (29.6 ml), NDC 69634-021-30, and lot number BNZ-001646 with an expiration date of 11/26/2026.
Look for the product name, NDC 69634-021-30, lot number BNZ-001646, and expiration date 11/26/2026 on the label.
The recall states the product was rejected by quality control but released to customers. No injuries have been reported, but the product may have been contaminated due to scratches in the mixing vessel.
The recall does not specify a remedy, so there is no action required beyond checking if you have the product.
Check for the product name 'Health-Tec Topical Anesthetic Gel', Benzocaine 20%, 1 fl. oz. (29.6 ml), NDC 69634-021-30, lot number BNZ-001646, and expiration date 11/26/2026.
We’ve drafted a message you can send Keystone Industries to request your refund or repair — edit it as you like.
Subject: Recall D-0142-2025 — Keystone Industries Keystone Industries Hello, I own a Keystone Industries that is covered by recall D-0142-2025 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.
