Drug product
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.
D-0231-2026
Product summary
- Event
- Event 98080
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,520 Cartons
- Official record key
drug-enforcement:D-0231-2026
Official wording
Reason: Defective container: cracked/broken cartridges
Code information: Lot: D05159G, expires: 07-31-2027
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Unknown
Defective container: cracked/broken cartridges