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FDARecalled Dec 24, 2025 · #D-0230-2026

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 Dents...

Hazard

Class II — temporary health risk

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Description

Defective container: cracked/broken cartridges Classification: Class II Distribution: U.S.A. Nationwide

Product details

Product
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.
Type
Drugs
Manufacturer
Novocol Pharmaceutical of Canada, Inc.
Model numbers
D05159C
UPCs