Recalling firm
Novocol Pharmaceutical of Canada, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-12-24
Distribution
U.S.A. Nationwide
Product quantity
1,636 cartons
Initiated by
Voluntary: Firm initiated
Reason for recall
Defective container: cracked/broken cartridges
Product description
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
Code / lot info
Lot: D05004E, expires: 04-30-2027
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.