Keystone Industries: Drug Recall
Recall #D-0138-2025 · 11/14/2024
Class II: Risk
Recall Details
- Recall Number
- D-0138-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Keystone Industries
- Status
- Ongoing
- Date Initiated
- 11/14/2024
- Location
- Gibbstown, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
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.
Product Description
M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co LL, 105-30 101 Avenue, Ozone Park, NY 11416.
Distribution Pattern
Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Other Recalls by Keystone Industries
- Class II: Risk 11/14/2024
- Class II: Risk 11/14/2024
- Class II: Risk 11/14/2024
- Class II: Risk 11/14/2024
- Class II: Risk 11/14/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.