FDA recall D-0828-2018

Septodont Inc. · Class III · drug

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.

Distribution

USA, Italy and France

Key facts

Status: Terminated
Initiation date: 2018-04-13
Report date: 2018-05-16
Termination date: 2020-12-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Louisville, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0828-2018