Drug product
3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI 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 66312-441-16.
D-0230-2026
Product summary
- Event
- Event 98080
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,825
- Official record key
drug-enforcement:D-0230-2026
Official wording
Reason: Defective container: cracked/broken cartridges
Code information: Lot: D05159C, expires: 07-31-2027
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Unknown
Defective container: cracked/broken cartridges