Recalls / Class II
Class IID-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
- Brand name
- Articadent
- Generic name
- Articaine Hydrochloride And Epinephrine Bitartrate
- Active ingredients
- Articaine Hydrochloride, Epinephrine Bitartrate
- Route
- Submucosal
- NDCs
- 66312-601, 66312-602
- FDA application
- NDA020971
- Affected lot / code info
- Lot # D02599A, exp. Sept 2020, D02608B, exp. October 2020
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.
Recalling firm
- Firm
- Septodont Inc.
- Manufacturer
- Dentsply Pharmaceutical
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 416 S Taylor Ave, N/A, Louisville, Colorado 80027-3028
Distribution
- Quantity
- 240 cartons of 50 glass cartridges each
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-05-02
- FDA classified
- 2019-05-28
- Posted by FDA
- 2019-05-29
- Terminated
- 2020-11-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1307-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.