FDAHealthOctober 31, 2025
Novocol Pharmaceutical of Canada, Inc. — 3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml
⚠️ Defective container: cracked/broken cartridges
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 31, 2025
U.S.A. Nationwide
What's affected?
- 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
- POLOCAINE
- Lot code
- D05159C
Additional details
Lot: D05159C, expires: 07-31-2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 5,825.
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