FDA-Drug2025-12-24Class IIPACKAGING DEFECT
OraVerse phentolamine mesylate injection recalled for cracked cartridges
What this means
OraVerse (phentolamine mesylate) injection cartridges in one lot have been found with cracks or breaks in the container. Affected cartons contain 10 cartridges each and were distributed nationwide. No injuries have been reported.
- Check if you have OraVerse lot D05004E (expires 04-30-2027)
- Do not use cartridges from affected cartons
- Contact your supplier or Septodont, Inc. for instructions on return or replacement
The agency's original wording
Hazard
Defective container: cracked/broken cartridges
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S.A. Nationwide
Affected count
1,636 cartons
Manufactured in
25 Wolseley Crt, Cambridge, Canada
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0234-2026Want us to check the next one for you?
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