Class II · Moderate risk
Lidocaine Ointment USP
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
Lidocaine HCI 2% and Epinephrine 1:100
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
Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Patterson Dental Supply, Inc., 1031 Mendota Heights Road, Saint Paul, MN55120, Manufactured by: Novocol Pharmaceutical of Canada, Inc., NDC 50227-1030-5.
Affected NDC
50227-1030-05
Compare with the code on your package — it is the most precise check available.
Drug: Lidocaine
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 |
|---|---|---|---|---|
| Lidocaine Lidocaine Hydrochloride and Epinephrine Bitartrate NDC 50227-1030 |
LIDOCAINE HYDROCHLORIDE 20 mg/mL; EPINEPHRINE BITARTRATE .01 mg/mL | Injection, Solution Submucosal |
Patterson Dental | Rx |
- Recalling firm
- Novocol Pharmaceutical of Canada, Inc.
- NDC code
- 50227-1030-5
- Origin
- Canada
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0229-2026 · 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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Class II · Moderate risk
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Class III · Low risk
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Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
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