Key Takeaway

FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01 by Custopharm, Inc. was recalled on July 30, 2021. The hazard: Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.

FDA Drug Class II Terminated

FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01

Recalled: July 30, 2021 ~19,384 vials units affected D-0765-2021

Description

FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01

Hazard / Reason

Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01

Drugs

Company Information

Custopharm, Inc.

Carlsbad, CA, United States

View all 1 recalls by Custopharm, Inc. →

Distribution

Distributed Nationwide in the USA

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Frequently Asked Questions

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Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.