Septodont Recalls Articadent Dental Cartridges Due to Carton Mislabeling
Septodont Inc. is recalling 240 cartons of Articadent dental cartridges because the printed cartons contained text for both Articadent and Xylocaine, though the cartridges themselves are correctly labeled.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error on the outer carton where the inner cartridges are correctly labeled, fitting the criteria for moderate severity.
Plain-English summary
Septodont Inc. is recalling 240 cartons of 50 glass cartridges each of Articadent (articaine hydrochloride and epinephrine bitartrate) due to mislabeling on the printed cartons. The affected lots are D02599A (exp. Sept 2020) and D02608B (exp. October 2020). The product was distributed nationwide in the USA.
The recall was initiated because the printed cartons used for 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, while Articadent DENTAL is a trade name for Articaine HCI 4% and Epinephrine 1:100,000. The cartridges contained within the printed cartons are labeled appropriately as Articadent DENTAL.
This recall is classified as FDA Class II. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If found, the product should be returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- ARTICADENT (ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
- Brand
- ARTICADENT
- Manufacturer
- Septodont Inc.
- Category
- Drug — Prescription Drug
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot # D02599A
- exp. Sept 2020
- D02608B
- exp. October 2020
UPCs (1)
- 0000004235644
Distribution
Distributed nationwide across the United States.
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