April 2018 FDA Recall Oraverse by Septodont Inc.
D-0828-2018 - Failed Impurities/Degradation

This Class III drug recall was voluntarily initiated by Septodont Inc. on April 13, 2018 for the product Oraverse. The FDA reported the reason for recall as failed impurities/degradation. The product was distributed in USA, Italy and France and the recall is currently terminated.

Recall Number: D-0828-2018

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.
Initiated
04-13-2018
Reported
05-16-2018
Quantity
8509 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79976
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Septodont Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA, Italy and France
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-14-2020
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 's D01894E and D01894G

Affected Packages Involved in this Recall

0362-0101-10 Oraverse