Keystone Industries 2024-12-25 Health serious FDA
Health · FDA · Recall #FDA-D-0139-2025
Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free,… Recall
Issued December 25, 2024 · Keystone Industries
In December 2024, Keystone Industries recalled the Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Keystone Industries to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Keystone Industries
- Category
- Health
- Recall date
- December 25, 2024
- Units affected
- Not reported
- Sold at
- Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
- Recall number
- FDA-D-0139-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Keystone Industries has 7 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.