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Novocol Pharmaceutical of Canada, Inc.: 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose

DrugsSource: FDA (drug) · Date: 2025-12-24

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Novocol Pharmaceutical of Canada, Inc.
Product
2% Xylocaine DENTAL with 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 Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-176-16.
Reason / hazard
Defective container: cracked/broken cartridges
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S.A. Nationwide
Recall initiated
2025-10-31
Code info
Lot: D05337B, expires: 06-30-2027
Product quantity
18,789 cartons- 50 cartridges /carton
Voluntary mandated
Voluntary: Firm initiated
City
Cambridge
Country
Canada
Event id
98080
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