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.
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
Lot numbers, UPCs & expiration codes
Lot # D02599A, exp. Sept 2020, D02608B, exp. October 2020
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1307-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 2, 2019
- FDA report date
- May 29, 2019
- Quantity
- 240 cartons of 50 glass cartridges each
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Septodont Inc.
Original FDA data
Every field from FDA enforcement report D-1307-2019, exactly as published.
Show all FDA fields
- City
- Louisville
- State
- CO
- Status
- Terminated
- Country
- United States
- Event ID
- 82760
- Address
- 416 S Taylor Ave
- Code information
- Lot # D02599A, exp. Sept 2020, D02608B, exp. October 2020
- Postal code
- 80027-3028
- Report date
- May 29, 2019
- Product type
- Drugs
- Recall number
- D-1307-2019
- Classification
- Class II
- Recalling firm
- Septodont Inc.
- Product quantity
- 240 cartons of 50 glass cartridges each
- Termination date
- Nov 19, 2020
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 2, 2019
- Initial firm notification
- Letter
- Center classification date
- May 28, 2019