Drug product
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.
D-0228-2026
Product summary
- Event
- Event 98080
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18,789 cartons- 50 cartridges /carton
- Official record key
drug-enforcement:D-0228-2026
Official wording
Reason: Defective container: cracked/broken cartridges
Code information: Lot: D05337B, expires: 06-30-2027
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Unknown
Defective container: cracked/broken cartridges