Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported May 16, 2018
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
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 degradati…
Septodont Inc. recalled OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartri… - a low-severity action.
OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartri… was recalled by Septodont Inc. in May 16, 2018. Reason: Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result tha…. Check the official notice for the remedy. Verify recall #D-0828-2018 with the FDA Drug before acting.
The recall
Septodont Inc. issued this low-severity FDA Drug recall-Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result tha….
- Low
- severity level
- Class III
- classification
- May 16, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0828-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0828-2018) was formally reported on May 16, 2018, with the manufacturer initiating the action on April 13, 2018. It is classified under Low severity (Class III), with a current status of Terminated. Septodont Inc. is listed as the recalling firm, operating out of Louisville, CO. Federal records list the affected scope as 8509 boxes.
The documented reason for this recall is: 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 stab… Distribution data in the federal record shows the product reached: USA, Italy and France. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,436 drugs & medications recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
8509 boxes
Related Recalls
6
6 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0828-2018 |
| Date reported | May 16, 2018 |
| Date initiated | April 13, 2018 |
| Recalling firm | Septodont Inc. |
| Firm location | Louisville, CO |
| Affected scope | 8509 boxes |
| Distribution | USA, Italy and France |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0828-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Septodont Inc.. Units affected: 8509 boxes.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 16, 2018. Severity: Low. Recall number: D-0828-2018.
Where was the recalled product distributed? ▼
Distribution: USA, Italy and France.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0828-2018) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nationwide recalls with similar severity or category timing
Two federal-filing-derived peer sets for this notice, both outside the same recalling firm and filing state so the neighborhoods are not firm or geographic containment.
Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
Similar Drugs & Medications · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported May 16, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.