FDAFDA · Food and drugs·Recall number D-0828-2018
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
Published May 16, 2018 · Recall initiated: April 13, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- ORAVERSE
- Manufacturer
- Septodont Inc.
- Distributor
- USA, Italy and France
- Lot
- Lot #'s D01894E and D01894G
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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