COMPANY ANNOUNCEMENT
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company’s announcement as a public service. FDA does not endorse either the product or the company.
Summary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
-
Recall Reason Description
Presence of particulate matter identified as steel
- Company Name:
- Sunny Pharmtech, Inc.
- Brand Name:
-
Brand Name(s)
Long Grove Pharmaceuticals
- Product Description:
-
Product Description
Cyclophosphamide for Injection
Company Announcement
| Product Name / Strength | Dosage Form / Package | NDC | Lot Number | Expiration Date |
|---|---|---|---|---|
| Cyclophosphamide for Injection, USP | 1 g/vial, 50mL vial | 81298-8112-1 | C23019V1 | Oct-2026 |
| Cyclophosphamide for Injection, USP | 1 g/vial, 50mL vial | 81298-8112-1 | C24015V1 | Apr-2027 |
| Cyclophosphamide for Injection, USP | 2 g/vial, 100 mL vial | 81298-8114-1 | V24010V1 | Mar-2027 |
Sunny PharmTech has notified FDA and its distributor, Cardinal Health, of this recall action and is coordinating with Long Grove Pharmaceuticals, LLC and Cardinal Health to notify pharmacies, hospitals, and other healthcare providers and to coordinate the return, reconciliation and destruction of the three lots of recalled product in accordance with the recall strategy.
| Online: | Complete and submit the report at www.fda.gov/medwatch/report.htm |
| Regular Mail: | Download the reporting form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a form; complete and return it to the address on the pre-addressed form. |
| Fax: | Submit the completed form to 1-800-FDA-0178. |
Product Photos
