Sunny Pharmtech Inc. has voluntarily recalled three lots of Cyclophosphamide for Injection, USP, after discovering steel particulate matter in the injectable cancer drug, prompting a nationwide recall to the user level, according to the U.S. Food and Drug Administration (FDA).
The FDA announced the recall on July 24, warning that patients who receive contaminated intravenous doses face a reasonable probability of serious adverse health consequences, including death.
No injuries or adverse events related to the recall have been reported to date.
Potentially Life-Threatening Risk
Cyclophosphamide is a chemotherapy drug used to treat a wide range of cancers, including Hodgkin’s lymphoma, leukemia, multiple myeloma, breast cancer, ovarian cancer, neuroblastoma, and retinoblastoma. It is also prescribed for certain pediatric patients with biopsy-confirmed minimal change nephrotic syndrome when corticosteroid therapy is ineffective or cannot be tolerated.
According to the FDA, the recalled products may contain steel particles, which could enter a patient’s bloodstream during intravenous infusion.
For cancer patients—many of whom are immunocompromised or have other underlying medical conditions—the contamination could lead to complications including:
- Phlebitis, or inflammation of the veins;
- Granulomas, or inflammatory tissue masses;
- Blood vessel blockages; and
- Potentially life-threatening thromboembolic events.
Recalled Lots
The recall affects the following Long Grove Pharmaceuticals-branded products manufactured by Sunny Pharmtech:
| Product | NDC | Lot Number | Expiration |
|---|---|---|---|
| Cyclophosphamide for Injection, USP 1 g/vial | 81298-8112-1 | C23019V1 | October 2026 |
| Cyclophosphamide for Injection, USP 1 g/vial | 81298-8112-1 | C24015V1 | April 2027 |
| Cyclophosphamide for Injection, USP 2 g/vial | 81298-8114-1 | V24010V1 | March 2027 |
The affected products were distributed to wholesalers, distributors, hospitals, and pharmacies between May and October 2024.
Healthcare Providers Told To Quarantine Product
Sunny Pharmtech said it notified the FDA and distributor Cardinal Health and is coordinating with Long Grove Pharmaceuticals to remove the affected products from circulation.
The company instructed hospitals, pharmacies, and other healthcare providers to:
- Immediately stop using and dispensing the recalled lots;
- Quarantine any remaining inventory; and
- Follow recall instructions for returning the affected products to Cardinal Health.
Patients Should Consult Their Physician
The FDA advises patients not to discontinue prescribed treatment on their own. Anyone who believes they may have received one of the recalled products or has experienced symptoms potentially related to the medication should contact their physician or healthcare provider.
Consumers with questions about the recall may contact Sunny Pharmtech at +886-3-480-9168, extension 7205, or by email at [email protected] during the company’s business hours.
Healthcare professionals and patients may also report adverse events associated with the recalled drug through the FDA’s MedWatch Adverse Event Reporting Program.
The recall is being conducted with the knowledge and oversight of the FDA.
