FDA-Drug2018-05-16Class III
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
Septodont Inc.
Hazard
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.
Sold states
USA, Italy and France
Affected count
8509 boxes
Manufactured in
416 S Taylor Ave, N/A, Louisville, CO, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0828-2018Don't want to check this manually?
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