3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), pac...
FDA Recall #D-0230-2026 — Class II — October 31, 2025
Product Description
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.
Reason for Recall
Defective container: cracked/broken cartridges
Recalling Firm
Novocol Pharmaceutical of Canada, Inc. — Cambridge
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
5,825
Distribution
U.S.A. Nationwide
Code Information
Lot: D05159C, expires: 07-31-2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated