Recalling firm
Novocol Pharmaceutical of Canada, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-12-24
Distribution
U.S.A. Nationwide
Product quantity
18,789 cartons- 50 cartridges /carton
Initiated by
Voluntary: Firm initiated
Reason for recall
Defective container: cracked/broken cartridges
Product description
2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine 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 66312-176-16.
Code / lot info
Lot: D05337B, expires: 06-30-2027
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.