# FDA recall D-0828-2018

> **Septodont Inc.** · Class III · drug recall initiated 2018-04-13.

## Product

OraVerse (Phentolamine Mesylate) Injection,  0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed by Septodont, Inc., Louisville, CO 80027, Made in Canada by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0101-10

## Reason for recall

Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance (Phentolamide), a known degradation product impurity at the 15 month stability test point.

## Distribution

USA, Italy and France

## Key facts

- **Recall number:** D-0828-2018
- **Recalling firm:** Septodont Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-04-13
- **Report date:** 2018-05-16
- **Termination date:** 2020-12-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Louisville, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0828-2018

## Citation

> AI Analytics. FDA recall D-0828-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0828-2018. Source: US FDA. Licensed CC0.

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