FDAFDA · Food and drugs·Recall number D-0230-2026
3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-441-16.
Published December 24, 2025 · Recall initiated: October 31, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective container: cracked/broken cartridges
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- POLOCAINE
- Manufacturer
- Novocol Pharmaceutical of Canada, Inc.
- Distributor
- U.S.A. Nationwide
- Lot
- Lot: D05159C, expires: 07-31-2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- Canada
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