Drug Enforcement D-0146-2025

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.

Status

Ongoing

Classification

Class II

Report Date

December 25, 2024

Termination Date

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Product Information

Product description
Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental Products, Made in USA for: NDC, Inc, 407 New Sanford Road, La Vergne, TN 37086, www.quala.com
Product quantity
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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.
Recall initiation reason
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Initial firm notification
E-Mail
Distribution pattern
Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.

Location & Firm

Recalling firm
Keystone Industries
Address
480 S Democrat Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0146-2025
Event ID
95854
Recall initiation date
November 14, 2024
Center classification date
December 13, 2024
Code info
Lot No.: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-64419
More code info
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