Recalls / Class II
Class IID-0230-2026
Product
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.
- Brand name
- Polocaine
- Generic name
- Mepivacaine Hydrochloride
- Active ingredient
- Mepivacaine Hydrochloride
- Route
- Submucosal
- NDC
- 66312-441
- FDA application
- ANDA088387
- Affected lot / code info
- Lot: D05159C, expires: 07-31-2027
Why it was recalled
Defective container: cracked/broken cartridges
Recalling firm
- Firm
- Novocol Pharmaceutical of Canada, Inc.
- Manufacturer
- Dentsply Pharmaceutical
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 25 Wolseley Crt, Cambridge, N/A, Canada
Distribution
- Quantity
- 5,825
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2025-10-31
- FDA classified
- 2025-12-12
- Posted by FDA
- 2025-12-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0230-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.