FDA-Drug2025-12-24Class II
3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI 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 66312-441-16.
Novocol Pharmaceutical of Canada, Inc.
Hazard
Defective container: cracked/broken cartridges
Sold states
U.S.A. Nationwide
Affected count
5,825
Manufactured in
25 Wolseley Crt, Cambridge, Canada
Products
3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI 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 66312-441-16.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0230-2026Don't want to check this manually?
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