Drug recall D-1307-2019
Product
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.
Lots and codes
Lot # D02599A, exp. Sept 2020, D02608B, exp. October 2020
Recall details
- Recalling firm
- Septodont Inc., Louisville, CO
- Quantity
- 240 cartons of 50 glass cartridges each
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 2, 2019
- Terminated
- November 19, 2020
Related products
- Articadent – drug information
- NDC 66312-601 Articadent · Articaine Hydrochloride 40 mg/mL; Epinephrine Bitartrate… · Dentsply Pharmaceutical
- NDC 66312-602 Articadent · Articaine Hydrochloride 40 mg/mL; Epinephrine Bitartrate… · Dentsply Pharmaceutical