Novocol Pharmaceutical of Canada, Inc. recalls OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL,…
- Recall date
- October 31, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0234-2026
- FDA classification
- Class II
- Brand / firm
- Novocol Pharmaceutical of Canada, Inc.
- Sold / distributed
- U.S.A. Nationwide
Why it was recalled
Defective container: cracked/broken cartridges
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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