FDAApril 13, 2018drug
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 recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
septodont
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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