D-0234-2026 Class II Ongoing
FDA drug recall D-0234-2026 was initiated by Novocol Pharmaceutical Of Canada, Inc. on Oct 31, 2025 and is designated Class II. Reason for recall: Defective container: cracked/broken cartridges The recall status is ongoing. Affected quantity: 1,636 cartons.
Recall details
- Product Type
- Drugs
- Report Date
- Dec 24, 2025
- Initiation Date
- Oct 31, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,636 cartons
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
Reason for recall
Defective container: cracked/broken cartridges
Distribution pattern
U.S.A. Nationwide
Code information
Lot: D05004E, expires: 04-30-2027
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0234-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026