Septodont Recalls OraVerse Injection Due to Impurity Test Failure
Septodont Inc. is recalling OraVerse (Phentolamine Mesylate) Injection due to an out-of-specification result for a degradation product impurity.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classifies this recall as 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.
Plain-English summary
Septodont Inc. is recalling 8,509 boxes of OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL. The product is packaged in boxes of 10 cartridges and is distributed in the USA, Italy, and France. The specific lots affected are D01894E and D01894G.
The recall was initiated because the product failed a stability test at the 15-month point. An out-of-specification (OOS) result was obtained for a related substance known as Phentolamide, which is a degradation product impurity.
Consumers and healthcare providers should stop using the affected lots and contact Septodont Inc. for further instructions or a return. This recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- ORAVERSE (PHENTOLAMINE MESYLATE)
- Brand
- ORAVERSE
- Manufacturer
- Septodont Inc.
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 8,509
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 (1)
- Lot #'s D01894E and D01894G
Distribution
Distribution scope not specified by the agency.
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