Health-Tec recall: CGMP Deviations
Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.
Why was Health-Tec 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 I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-28119
- Product
- Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.
- Recalling firm
- Keystone Industries
- Distribution
- Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
- Recall date
- December 25, 2024
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)