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FDAOctober 31, 2025drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

Defective container: cracked/broken cartridges

What to do

FDA enforcement status: Ongoing

Brands named

novocol pharmaceuticalnovocol

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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