D-0127-2021 Class III Terminated
FDA drug recall D-0127-2021 was initiated by Novocol Pharmaceutical of Canada, Inc. on November 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
- December 16, 2020
- Initiation Date
- November 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