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
Recall Summary Polocaine 3% dental anesthetic in cartridge form is being recalled nationwide because some cartridges are cracked or broken. The product is a prescription local anesthetic used by dentists, manufactured by Novocol Pharmaceutical of Canada for Dentsply. This is a serious (Class I) recall that affects dental practices and suppliers across all U.S. states.
- Recalling firm
- Novocol Pharmaceutical of Canada, Inc.
- Product
- 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
- Defective container: cracked/broken cartridges
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2025-10-31
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S.A. Nationwide
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/2c5c9f66-b5c0-41ba-a232-7a50ce22ecbf