Recalls / Class III
Class IIID-0828-2018
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
- Brand name
- Oraverse
- Generic name
- Phentolamine Mesylate
- Active ingredient
- Phentolamine Mesylate
- Route
- Submucosal
- NDC
- 0362-0101
- FDA application
- NDA022159
- Affected lot / code info
- Lot #'s D01894E and D01894G
Why it was 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.
Recalling firm
- Firm
- Septodont Inc.
- Manufacturer
- Septodont, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 416 S Taylor Ave, N/A, Louisville, Colorado 80027-3028
Distribution
- Quantity
- 8509 boxes
- Distribution pattern
- USA, Italy and France
Timeline
- Recall initiated
- 2018-04-13
- FDA classified
- 2018-05-22
- Posted by FDA
- 2018-05-16
- Terminated
- 2020-12-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0828-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.