Class II · Moderate risk
Cook-Walte
Defective container: cracked/broken cartridges
3% Polocaine DENTAL (Mepivacaine Hydrochloride)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective container: cracked/broken cartridges
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
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.
Affected NDC
66312-0441-16
Compare with the code on your package — it is the most precise check available.
Drug: Mepivacaine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Polocaine Mepivacaine Hydrochloride NDC 66312-0441 |
30 mg/mL | Injection, Solution Submucosal |
Dentsply Pharmaceutical | Rx |
- Recalling firm
- Novocol Pharmaceutical of Canada, Inc.
- NDC code
- 66312-441-16
- Origin
- Canada
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0230-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
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