Recalling firm
Novocol Pharmaceutical of Canada, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-12-24
Distribution
U.S.A. Nationwide
Product quantity
5,520 Cartons
Initiated by
Voluntary: Firm initiated
Reason for recall
Defective container: cracked/broken cartridges
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.
Code / lot info
Lot: D05159G, expires: 07-31-2027
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.