Recalls / Class III
Class IIID-0127-2021
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
- Brand name
- Scandonest 3% Plain
- Generic name
- Mepivacaine Hydrochloride
- Active ingredient
- Mepivacaine Hydrochloride
- Route
- Subcutaneous
- NDC
- 0362-1098
- FDA application
- ANDA088387
- Affected lot / code info
- 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
Why it was recalled
Labeling: Label mix-up
Recalling firm
- Firm
- Novocol Pharmaceutical of Canada, Inc.
- Manufacturer
- Septodont, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 25 Wolseley Crt, N/A, Cambridge, N/A N/A, Canada
Distribution
- Quantity
- 15,398 cartridges
- Distribution pattern
- U.S. nationwide.
Timeline
- Recall initiated
- 2020-11-20
- FDA classified
- 2020-12-09
- Posted by FDA
- 2020-12-16
- Terminated
- 2021-05-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0127-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.