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Drug recall · FDA · Published December 4, 2017

AuroMedics Pharma LLC recalls Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics

AuroMedics recalls Pantoprazole Sodium 40mg injection vials due to glass particles found in one lot. This poses a risk of injury from glass fragments if injected.

🇺🇸 FDA recall #D-0340-2018DrugAuroMedics ›
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Contact the company & request your remedy

Recalling firmAuroMedics Pharma LLC279 Princeton Hightstown Rd, N/A · East Windsor, NJ 08520-1401
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

AuroMedics is recalling Pantop: 40mg injection vials that contained glass particles. Using these vials could cause injury from glass fragments during injection. Read more at govinfonow.com/recall/41032-auromedics-pantoprazole-sodium-injection-recall-glass-particulate-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/41032-auromedics-pantoprazole-sodium-injection-recall-glass-particulate-hazard · Updated October 7, 2026 · FDA enforcement record: FDA #D-0340-2018

Cite this page

“AuroMedics Pantoprazole Sodium Injection Recall: Glass Particulate Hazard.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41032-auromedics-pantoprazole-sodium-injection-recall-glass-particulate-hazard. Based on FDA recall #D-0340-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0340-2018%22&limit=1).

Why it’s dangerous

Glass particles in the vial could cause injury if injected. This is a rare occurrence but can lead to tissue damage or other complications.

Who’s affected

Patients prescribed Pantoprazole Sodium for Injection 40mg by a doctor. Those who received the specific lot number CPO170035 are most at risk.

How to tell if you have this one

Check for the lot number CPO170035 on the vial label. The product is a 40mg single-dose injection vial manufactured in India by AuroMedics.

  • Brand
    AuroMedics
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Vial Label

    Look for the lot number CPO170035 on the vial label to confirm if it's affected.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall is for one specific lot (CPO170035) that contained glass particles. Other lots are safe.

How can I tell if I have the recalled product?

Check the vial label for the lot number CPO170035. The product is a 40mg single-dose injection vial manufactured in India by AuroMedics.

What should I do if I have the recalled product?

Check the vial label for the lot number CPO170035. If it matches, contact your doctor or pharmacist for guidance.

Take action

Contact AuroMedics

We’ve drafted a message you can send AuroMedics to request your refund or repair — edit it as you like.

Subject: Recall D-0340-2018 — AuroMedics AuroMedics

Hello,

I own a AuroMedics that is covered by recall D-0340-2018 from AuroMedics.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0340-2018 (December 4, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0340-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA