FDA-Drug2025-12-24Class II
2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-176-16.
Novocol Pharmaceutical of Canada, Inc.
Hazard
Defective container: cracked/broken cartridges
Sold states
U.S.A. Nationwide
Affected count
18,789 cartons- 50 cartridges /carton
Manufactured in
25 Wolseley Crt, Cambridge, Canada
Products
2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-176-16.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0228-2026Don't want to check this manually?
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