Reported May 29, 2019 · Terminated
Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 cartridges. 1.7 mL each, Rx only,…
Septodont Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Septodont Inc. · 416 S Taylor Ave · Louisville, CO · 80027-3028
Is this the product you have?
- Articaine DENTAL, Articane hydrochloride 4%
- and epinephrine 1
10000050 cartridges. 1.7 mL eachRx only
- Manufactured forDENTSPLY Pharmaceutical, by Novocol Pharmaceutical of Canada, Inc. York, PA 17404, NDC 66312-601-16 Reorder #: 51116
- Lot codes and dates
Lot # D02599Aexp. Sept 2020D02608Bexp. October 2020
- Amount recalled
- 240 cartons of 50 glass cartridges each
Where it was sold
- Nationwide
Why it was recalled
Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used in manufacturing both batches contained text for both 2% Xylocaine DENTAL and Articadent DENTAL. Xylocaine DENTAL is a trade name for Lidocaine HCL 2% and Epinephrine 1: 100,000 formulation, while Articadent DENTAL is a trade name for Articaine HCI 4% and Epinephrine 1 :100,000. The cartridges contained within the printed carton are labeled appropriately as Articadent DENTAL.
This product could cause temporary or reversible health problems — stop using it.
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