Class II U.S. Food and Drug Administration

Novocol Pharmaceutical of Canada, Inc. OraVerse, Injection, 0.4 mg/1.7mL recall: Defective container: cracked/broken cartridges

Recall published 10 months ago

Defective container: cracked/broken cartridges

The hazard: Drug safety concern

This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

What the notice says: Defective container: cracked/broken cartridges

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Recall number
D-0234-2026
Published
December 24, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Novocol Pharmaceutical of Canada, Inc.
Product type
Prescription & OTC drugs
Units affected
1,636 cartons
Distribution
Nationwide
Made in
Canada
Lot / code info
Lot: D05004E, expires: 04-30-2027

Products covered by this recall

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

Check your product

The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • D05004E

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 04-30-2027 — 1
  • 636 cartons

NDC number

On the carton and again on the bottle or blister label.

  • 0362-0101-10

Package size

Match the net weight or the piece count on the front of the pack.

  • 0.4 mg
  • 1.7 mL

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Novocol Pharmaceutical of Canada, Inc. — This is an FDA enforcement action. The summary above is the agency’s own description of what went wrong.

  1. Check the lot number on your pack against the codes listed above.
  2. Report side effects you think the product caused to FDA MedWatch.
  3. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.
  4. Ask the dispensing pharmacy for a replacement from an unaffected lot.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: Novocol Pharmaceutical of Canada, Inc. — 25 Wolseley Crt, Cambridge

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Novocol Pharmaceutical of Canada, Inc. prescription & otc… recalled?

Defective container: cracked/broken cartridges Defective container: cracked/broken cartridges

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code D05004E; best-by date 04-30-2027 — 1 or 636 cartons. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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