FDA-Drug2025-12-24Class IIPACKAGING DEFECT
Novocol Mepivacaine HCI injection recalled for defective cracked cartridges
What this means
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
The agency's original wording
Hazard
Defective container: cracked/broken cartridges
Intended for
Adults
Illnesses reported
None reported
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-0231-2026Want us to check the next one for you?
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