FDAFDA · Food and drugs·Recall number D-0127-2021
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
Published December 16, 2020 · Recall initiated: November 20, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Label mix-up
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SCANDONEST 3% PLAIN
- Manufacturer
- Novocol Pharmaceutical of Canada, Inc.
- Distributor
- U.S. nationwide.
- UPC
- 0000001070354
- Lot
- 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
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- Canada
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