Louisville, CO, United States
Septodont Inc. recalls
2 recalls recorded since 2018, most recently on 2 May 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 2 May 2019
- Terminated
- 19 November 2020
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1307-2019
- 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
Terminated Class III Drugs
- Recall started
- 13 April 2018
- Terminated
- 14 December 2020
- Reason
- Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance (Phentolamide), a known degradation product impurity at the 15 month stability test point.
- Distribution
- USA, Italy and France
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0828-2018
- OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed by Septodont, Inc., Louisville, CO 80027, Made in Canada by Novocol Pharmaceutical o
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.