Novocol Recalls Scandonest 3% Plain Due to Labeling Mix-Up
Novocol Pharmaceutical is recalling 15,398 cartridges of Scandonest 3% Plain (Mepivacaine Hydrochloride) due to a label mix-up. The product is distributed nationwide.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The specific hazard is a labeling mix-up, which falls under the 'Low' severity criteria for documentation or packaging issues.
Plain-English summary
Novocol Pharmaceutical of Canada, Inc. is recalling 15,398 cartridges of Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor). The recall is being conducted due to a labeling issue described as a label mix-up. The product is a prescription-only dental anesthetic packaged in cartons of 50 cartridges.
The affected product is manufactured for SEPTODONT, Inc. and distributed nationwide in the United States. The recall covers specific batches with expiration dates ranging from January 2021 to February 2022, including batch numbers D03050E, D03032F, D02983D, D02865C, D02894G, D02701G, and D02766E.
The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should check their inventory for the specific batch numbers and expiration dates listed in the recall notice.
The recalled product
- Product
- SCANDONEST 3% PLAIN (MEPIVACAINE HYDROCHLORIDE)
- Brand
- SCANDONEST 3% PLAIN
- Manufacturer
- Novocol Pharmaceutical of Canada, Inc.
- Category
- Drug — Dental Anesthetic
- Hazard
- Affected units
- 15,398
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 (13)
- Batch # D03050E
- D03032F
- Exp 28-Feb-2022
- D02983D
- Exp 30-Nov-2021
- D02865C
- Exp 31-Aug-2021
- D02894G
- Exp 30-Sep-2021
- D02701G
- Exp 31-Jan-2021
- D02766E
- Exp 30-Apr-2021
UPCs (1)
- 0000001070354
Distribution
Distributed nationwide across the United States.
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