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
Check against the official notice below — it lists the full affected range.
Septodont Inc. is recalling Articadent DENTAL (Articaine hydrochloride 4% and epinephrine 1:100,000) distributed nationwide in the USA due to mislabeling on the carton. The printed cartons for two batches contained text describing both Xylocaine DENTAL (a lidocaine formulation) and Articadent DENTAL, even though the cartridges inside were correctly labeled as Articadent DENTAL. The recall affects 240 cartons containing 50 glass cartridges each, specifically Lot # D02599A (expiration September 2020) and Lot # D02608B (expiration October 2020).
The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: Nationwide in the USA Quantity: 240 cartons of 50 glass cartridges each Lot/code info: Lot # D02599A, exp. Sept 2020, D02608B, exp. October 2020
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.