Darby Dental Supply, Mepivacaine, Mepivacaine Hci 3% (30mg/ml) Injection, [mepivacaine Hci Injection, Usp], Packaged In A Carton Containing 50 Single-dose Cartridges, 1.7 Ml Each, Rx Only, Manufactur

Recall Summary Mepivacaine HCI 3% injection cartridges made by Novocol Pharmaceutical are being recalled nationwide because some cartridges have cracks or breaks in their containers. This is a Class I recall, meaning the defect could cause serious harm. The affected product is sold by Darby Dental Supply in boxes of 50 cartridges (NDC 66467-9760-5) and is a prescription-only anesthetic used in dental procedures.

Recalling firm

Novocol Pharmaceutical of Canada, Inc.

Product

darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66467-9760-5.

Reason

Defective container: cracked/broken cartridges

Classification

Class I

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2025-10-31

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

U.S.A. Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/3598ef83-26b6-47fe-920a-0f82b179ac86