Drug product
Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL each), Rx only, Manufactured for SEPTODONT, Inc., Louisville, CO 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, ON N1R 6X3, Canada, NDC 0362-1098-90
D-0127-2021
Product summary
- Event
- Event 86867
- Status
- Terminated
- Classification
- Class III
- Quantity
- 15,398 cartridges
- Official record key
drug-enforcement:D-0127-2021
Official wording
Reason: Labeling: Label mix-up
Code information: Batch # D03050E, D03032F, Exp 28-Feb-2022; D02983D, Exp 30-Nov-2021; D02865C, Exp 31-Aug-2021; D02894G, Exp 30-Sep-2021; D02701G, Exp 31-Jan-2021; D02766E, Exp 30-Apr-2021
Distribution pattern: U.S. nationwide.
Derived failure modes
-
Labeling or packaging
Labeling: Label mix-up