Drug 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
D-0234-2026
Product summary
- Event
- Event 98080
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,636 cartons
- Official record key
drug-enforcement:D-0234-2026
Official wording
Reason: Defective container: cracked/broken cartridges
Code information: Lot: D05004E, expires: 04-30-2027
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Unknown
Defective container: cracked/broken cartridges