darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Inject...
FDA Recall #D-0231-2026 — Class II — October 31, 2025
Product Description
darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66467-9760-5.
Reason for Recall
Defective container: cracked/broken cartridges
Recalling Firm
Novocol Pharmaceutical of Canada, Inc. — Cambridge
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
5,520 Cartons
Distribution
U.S.A. Nationwide
Code Information
Lot: D05159G, expires: 07-31-2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated