Why it was recalled
Labeling: Label mix-up
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
U.S. nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0127-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 20, 2020
- FDA report date
- Dec 16, 2020
- Quantity
- 15,398 cartridges
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novocol Pharmaceutical of Canada, Inc.
Original FDA data
Every field from FDA enforcement report D-0127-2021, exactly as published.
Show all FDA fields
- City
- Cambridge
- Status
- Terminated
- Country
- Canada
- Event ID
- 86867
- Address
- 25 Wolseley Crt
- 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
- Report date
- Dec 16, 2020
- Product type
- Drugs
- Recall number
- D-0127-2021
- Classification
- Class III
- Recalling firm
- Novocol Pharmaceutical of Canada, Inc.
- Product quantity
- 15,398 cartridges
- Termination date
- May 13, 2021
- Reason for recall
- Labeling: Label mix-up
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- U.S. nationwide.
- Recall initiation date
- Nov 20, 2020
- Initial firm notification
- Letter
- Center classification date
- Dec 9, 2020