D-0828-2018 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 16, 2018
- Initiation Date
- April 13, 2018
- Termination Date
- December 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8509 boxes
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.
Distribution Pattern
USA, Italy and France
Code Information
Lot #'s D01894E and D01894G