Drug recall D-0828-2018
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.
Lots and codes
Lot #'s D01894E and D01894G
Recall details
- Recalling firm
- Septodont Inc., Louisville, CO
- Quantity
- 8509 boxes
- Distribution
- USA, Italy and France
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 13, 2018
- Terminated
- December 14, 2020
Related products
- Oraverse – drug information
- NDC 0362-0101 Oraverse · Phentolamine Mesylate .235 mg/mL · Septodont, Inc.