Oraverse, (phentolamine Mesylate) Injection, 0.4 Mg/1.7ml, Packaged In A Carton Containing 10 Cartridges, 0.4 Mg/1.7ml, Rx Only, Made In Canada By Novocol Pharmaceutical Of Canada, Inc., Distributed B
OraVerse Recall Summary OraVerse (Phentolamine Mesylate) injection cartridges are being recalled nationwide because some cartridges are cracked or broken. The affected product is the 0.4 mg/1.7mL carton containing 10 cartridges, distributed by Septodont, Inc. This is a serious recall (Class I) affecting dental offices and clinics across all U.S. states and Washington, D.C.
- Recalling firm
- Novocol Pharmaceutical of Canada, Inc.
- Product
- OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Canada by Novocol Pharmaceutical of Canada, Inc., Distributed by Septodont, Inc., Louisville, Co, 80027, NDC 0362-0101-10
- Reason
- Defective container: cracked/broken cartridges
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2025-10-31
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S.A. Nationwide
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/1c86f723-5d50-417e-b979-1b65fdc02d63