OraVerse — Class III drug recall D-0828-2018
Terminated recall by Septodont Inc., reported 2018-05-16. Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that
| Recall number | D-0828-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Septodont Inc., Louisville, CO, United States |
| Recall initiated | 2018-04-13 |
| Classified | 2018-05-22 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2020-12-14 |
| Countries outside the US | FR, IT |
| Quantity | 8,509 boxes |
| Reason classes | specification failure |
| NDC | 00362-0101, 00362-0101-10 |
| Lot numbers | D01894E, D01894G |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0828-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.