FDA-Drug2025-12-24Class IIPACKAGING DEFECT
Novocol Mepivacaine HCI injection recalled for defective cracked cartridges
GLASSNationwide distribution
Stop using Novocol Mepivacaine injection cartridges
Novocol Pharmaceutical's Mepivacaine HCI 3% injection cartridges may have cracked or broken containers. This defect affects one lot (D05159G) distributed nationwide. The cracked cartridges could compromise the integrity of the medication.
- Check your supply for lot D05159G (expires 07-31-2027)
- Stop using any cartridges from this lot immediately
- Contact your dental supplier or pharmacy for a replacement
- Do not use compromised cartridges on patients
Hazard
Defective container: cracked/broken cartridges
Sold states
U.S.A. Nationwide
Affected count
5,520 Cartons
Manufactured in
25 Wolseley Crt, Cambridge, Canada
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0231-2026Don't want to check this manually?
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