FDA Drug Class II — Moderate

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.

Hazard

Defective container: cracked/broken cartridges

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Products

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
Brand
Novocol Pharmaceutical of Canada, Inc.
UPC
Lot: D05337B, expires: 06-30-2027

Units Affected

18,789 cartons- 50 cartridges /carton

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