D-1307-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 29, 2019
- Initiation Date
- May 2, 2019
- Termination Date
- November 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 240 cartons of 50 glass cartridges each
Product Description
Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000, 50 cartridges. 1.7 mL each, Rx only, Manufactured for: DENTSPLY Pharmaceutical, by Novocol Pharmaceutical of Canada, Inc. York, PA 17404, NDC 66312-601-16 Reorder #: 51116
Reason for Recall
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # D02599A, exp. Sept 2020, D02608B, exp. October 2020