Moderate riskFDA DrugClass II

Safco SensiCaine-Ultra benzocaine gel recalled for incomplete bottle seals

Safco SensiCaine-Ultra topical anesthetic gel bottles may have incomplete seals, which could allow the product to leak or become contaminated. This affects 150 units distributed nationwide. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Check your SensiCaine-Ultra bottle (NDC 67239-0223-1, expiration 04/15/2029) for signs of leakage or damage.
  2. Do not use the product if the seal appears broken or incomplete.
  3. Contact Safco Dental Supply Co. or your supplier for instructions on returning or replacing the affected bottles.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 7 products — see all of them.

Details

Units affected
150 units
Illnesses reported
None reported
Manufactured in
480 S Democrat Rd, Gibbstown, NJ, United States
Classification
Class II
Recall number
D-0606-2026

In the FDA's words

Description
safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1. Defective container:may contain bottles with incomplete seals BNZ-001921, Exp 04/15/2029 Distribution: Nationwide in the USA Affected quantity: 150 units
Hazard
Defective container:may contain bottles with incomplete seals

7 products in this recall

Pearson, Quala and more benzocaine gels recalled for incomplete seals

Keystone Industries is recalling 7 topical anesthetic gels containing 20% benzocaine, sold as Pearson Quality, Quala, DHP, Burkhart, Dental City, PureLife, and safco SensiCaine-Ultra. The recall is due to a container defect: some bottles may have incomplete seals. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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