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Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons o...

FDA Recall #D-0127-2021 — Class III — November 20, 2020

Recall #D-0127-2021 Date: November 20, 2020 Classification: Class III Status: Terminated

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

Recalling Firm

Novocol Pharmaceutical of Canada, Inc. — Cambridge, N/A

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

15,398 cartridges

Distribution

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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