Data Composite

Recall D-0228-2026

US Class II Ongoing · initiated 2025-10-31

Recalling firm

Novocol Pharmaceutical of Canada, Inc.

Product

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.

Reason for recall

Defective container: cracked/broken cartridges

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