Long Grove Cyclophosphamide Injection Recall: Steel Particulate Hazard in Three Lots
Urgent safety alert: Long Grove Pharmaceuticals is voluntarily recalling three nationwide lots of Cyclophosphamide for Injection, USP (1-g and 2-g single-dose vials) after routine tests found steel particulates in the sterile powder. Health-care facilities must stop dispensing the affected vials at once, quarantine existing stock, and follow the return instructions in the official recall notice. Patients should not receive medication from these lots under any circumstance.
Why Long Grove Cyclophosphamide Injection Was Recalled
Manufacturer Sunny Pharmtech, Inc. detected visible steel particles during in-process quality checks. Infusing a solution that contains metal fragments may lead to:
- Phlebitis or granuloma at the IV site
- Thromboembolism, stroke, or myocardial infarction
- Multi-organ damage or death—especially in immunocompromised oncology patients
Recalled Lots and How to Verify Your Inventory
| Strength / Package | NDC | Lot | Expiration |
|---|---|---|---|
| 1 g / 50 mL vial | 81298-8112-1 | C23019V1 | Oct 2026 |
| 1 g / 50 mL vial | 81298-8112-1 | C24015V1 | Apr 2027 |
| 2 g / 100 mL vial | 81298-8114-1 | V24010V1 | Mar 2027 |
What Pharmacies, Clinics, and Hospitals Must Do Now
- Immediately quarantine all vials from the three recalled lots.
- Contact Cardinal Health using the recall notice to arrange product return and destruction.
- Document and report any adverse reactions to FDA MedWatch at fda.gov/medwatch/report.htm.
Guidance for Patients and Caregivers
- Do not use vials bearing the recalled lot numbers.
- If you suspect you received Long Grove Cyclophosphamide from a recalled lot, call your oncologist or pharmacist right away.
- Continue chemotherapy or nephrotic-syndrome treatment only under professional supervision—never discontinue on your own.
Sources
Official Recall Images
Key Recall Contact Information
Sunny Pharmtech Recall Hotline: +886-3-480-9168 ext. 7205 (Mon–Fri, 09:00–17:00 GMT+8)
Email: ra@sunnypharmtech.com
Long Grove Cyclophosphamide Recall – Frequently Asked Questions
1. Why is Long Grove Cyclophosphamide Injection being recalled?
Steel particles were discovered in finished vials, posing a risk of blood clots, organ damage, or death if infused.
2. Which lots of Long Grove Cyclophosphamide are affected by the recall?
Lots C23019V1 and C24015V1 (1-g vials) and lot V24010V1 (2-g vials) distributed nationwide between May and October 2024.
3. Can I exchange recalled Long Grove Cyclophosphamide vials for safe product?
Yes. Pharmacies will coordinate with Cardinal Health to replace product after recalled vials are returned.
4. I had chemotherapy last week—how do I know if Long Grove Cyclophosphamide from a recalled lot was used?
Contact the infusion center or pharmacy that prepared your treatment; they can cross-check the lot numbers recorded in your medication log.
5. How do I report a side effect linked to recalled Long Grove Cyclophosphamide?
Submit a report to FDA MedWatch online, or by mail/fax using Form 3500 found on the FDA website.
6. Will the Long Grove Cyclophosphamide shortage impact my chemotherapy schedule?
Your oncologist can prescribe alternative FDA-approved cyclophosphamide products or adjust your regimen to avoid treatment delays.