Medications & Supplements/Prescription Drugs

Custopharm, Inc.: Fludarabine Phosphate for Injection Recalled for Sterility Concerns

Agency Publication Date: August 20, 2021

Summary

Custopharm, Inc. is recalling 19,384 vials of Fludarabine Phosphate for Injection, USP (50 mg per vial), a prescription cancer medication manufactured for Leucadia Pharmaceuticals. The recall was initiated because the manufacturing facility detected microbial growth during environmental monitoring in aseptic (sterile) production areas. No injuries or infections have been reported to date, but the lack of sterility assurance poses a risk for patients receiving the injection. Consumers should contact their healthcare provider or pharmacist regarding this nationwide recall.

Risk

The drug is intended for injection, and a lack of sterility assurance means the product could be contaminated with microorganisms. If a non-sterile drug is injected, it can lead to serious, potentially life-threatening systemic infections.

What You Should Do

Check your medication vials for the product name 'FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial' and the NDC number 24201-237-01.
Identify if your product is affected by looking for Lot number 31327913C with an expiration date of 10/2022.
If you have the affected medication, contact your healthcare provider or pharmacist immediately for guidance on using an alternative supply.
Return any unused vials from Lot 31327913C to the pharmacy where you received them for a refund.
Contact Custopharm, Inc. or Leucadia Pharmaceuticals for further instructions regarding the return process.
Report any adverse reactions or quality problems to the FDA's MedWatch program.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: FLUDARABINE PHOSPHATE FOR INJECTION, USP (50 mg per vial)

Model:

NDC 24201-237-01

Recall #: D-0765-2021

Lot Numbers:

31327913C (Exp. Date 10/2022)

Date Ranges: 10/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88489

Status: Resolved

Manufacturer: Custopharm, Inc.

Sold By: Leucadia Pharmaceuticals

Manufactured In: United States

Units Affected: 19,384 vials

Distributed To: Nationwide

Agency Last Updated: August 23, 2021

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication vials for the product name 'FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial' and the NDC number 24201-237-01.

Identify if your product is affected by looking for Lot number 31327913C with an expiration date of 10/2022.

If you have the affected medication, contact your healthcare provider or pharmacist immediately for guidance on using an alternative supply.

Return any unused vials from Lot 31327913C to the pharmacy where you received them for a refund.

Contact Custopharm, Inc. or Leucadia Pharmaceuticals for further instructions regarding the return process.

Report any adverse reactions or quality problems to the FDA's MedWatch program.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.