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
Reported: December 16, 2020 Initiated: November 20, 2020 #D-0127-2021
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
Details
- Recalling Firm
- Novocol Pharmaceutical of Canada, Inc.
- Units Affected
- 15,398 cartridges
- Distribution
- U.S. nationwide.
- Location
- Cambridge, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Novocol Pharmaceutical of Canada, Inc.. Units affected: 15,398 cartridges.
Why was this product recalled? ▼
Labeling: Label mix-up
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 16, 2020. Severity: Low. Recall number: D-0127-2021.
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