D-0127-2021 Class III Terminated
FDA drug recall D-0127-2021 was initiated by Novocol Pharmaceutical Of Canada, Inc. on Nov 20, 2020 and is designated Class III. Reason for recall: Labeling: Label mix-up The recall status is terminated (terminated May 13, 2021). Affected quantity: 15,398 cartridges.
Recall details
- Product Type
- Drugs
- Report Date
- Dec 16, 2020
- Initiation Date
- Nov 20, 2020
- Termination Date
- May 13, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,398 cartridges
Product description
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
Reason for recall
Labeling: Label mix-up
Distribution pattern
U.S. nationwide.
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0127-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026