Benco Dental Graham Chemical Co., Mepivacaine Hci 3% (30 Mg/ml) Injection, [mepivacaine Hci Injection, Usp], Packaged In A Carton Containing 50 Single-dose Cartridges, 1.7 Ml Each, Rx Only, Distribute
Recall Summary Benco Dental is recalling Mepivacaine HCI 3% injection (a local anesthetic used by dentists) distributed nationwide because some cartridges in the packages are cracked or broken. The affected product is packaged in cartons containing 50 single-dose cartridges manufactured by Novocol Pharmaceutical of Canada, Inc. This is a serious recall because defective containers could compromise the sterility and safety of the medication.
- Recalling firm
- Novocol Pharmaceutical of Canada, Inc.
- Product
- Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distributed by Benco Dental 295 Center Point Blvd, Pittston, PA 18640, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66975-406-51.
- 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/0d924bd6-8824-4404-8d03-cdea853a6e60