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.
Reported: December 24, 2025 Initiated: October 31, 2025 #D-0228-2026
Product Description
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
Details
- Recalling Firm
- Novocol Pharmaceutical of Canada, Inc.
- Units Affected
- 18,789 cartons- 50 cartridges /carton
- Distribution
- U.S.A. Nationwide
- Location
- Cambridge
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Novocol Pharmaceutical of Canada, Inc.. Units affected: 18,789 cartons- 50 cartridges /carton.
Why was this product recalled? ▼
Defective container: cracked/broken cartridges
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 24, 2025. Severity: Moderate. Recall number: D-0228-2026.
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