Septodont Inc. recalls OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx on…

Recall date

April 13, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0828-2018

FDA classification

Class III

Brand / firm

Septodont Inc.

Sold / distributed

USA, Italy and France

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.

Class III means the product violates regulations but is not likely to cause harm.

What 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