FDA-Drug2025-12-24Class IIPACKAGING DEFECT
Novocol Mepivacaine HCI injection recalled for cracked cartridges
What this means
Benco Dental is recalling Mepivacaine HCI 3% injection cartridges (lot D05159H, expires 07-31-2027) because some cartridges may be cracked or broken. A defective container could allow the medication to leak or become contaminated. No injuries have been reported.
- Stop using Mepivacaine HCI cartridges from lot D05159H immediately
- Contact Benco Dental or your supplier about returning or replacing affected cartridges
- Check your inventory for lot D05159H and set aside any affected units
The agency's original wording
Hazard
Defective container: cracked/broken cartridges
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S.A. Nationwide
Manufactured in
25 Wolseley Crt, Cambridge, Canada
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0232-2026Want us to check the next one for you?
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