Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC# 68400-352-30.
Reported: December 25, 2024 Initiated: November 14, 2024 #D-0137-2025
Product Description
Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC# 68400-352-30.
Reason for Recall
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.
Details
- Recalling Firm
- Keystone Industries
- Distribution
- Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
- Location
- Gibbstown, NJ
Frequently Asked Questions
What product was recalled? ▼
Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC# 68400-352-30.. Recalled by Keystone Industries.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 25, 2024. Severity: Moderate. Recall number: D-0137-2025.
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