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
Reported: September 1, 2021 Initiated: July 30, 2021 #D-0765-2021
Product 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
Reason for Recall
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
Details
- Recalling Firm
- Custopharm, Inc.
- Units Affected
- 19,384 vials
- Distribution
- Distributed Nationwide in the USA
- Location
- Carlsbad, CA
Frequently Asked Questions
What product was recalled? ▼
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 by Custopharm, Inc.. Units affected: 19,384 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 1, 2021. Severity: Moderate. Recall number: D-0765-2021.
Related Recalls
FDA Drug Moderate
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: U…
Unichem Pharmaceuticals USA Inc. · 2026-02-11
FDA Drug Critical
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San…
Green Lumber Holdings, LLC · 2026-02-11
FDA Drug Moderate
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500…
Granules Pharmaceuticals Inc. · 2026-02-11
FDA Drug Critical
Diclofenac Sodium, Topical Gel, 3%, 100 g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1…
SUN PHARMACEUTICAL INDUSTRIES INC · 2026-02-11
FDA Drug Critical
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313
HANDELNINE GLOBAL LLC · 2026-02-11