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.
Reported: December 24, 2025 Initiated: October 31, 2025 #D-0230-2026
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
Details
- Recalling Firm
- Novocol Pharmaceutical of Canada, Inc.
- Units Affected
- 5,825
- Distribution
- U.S.A. Nationwide
- Location
- Cambridge
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Novocol Pharmaceutical of Canada, Inc.. Units affected: 5,825.
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-0230-2026.
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