Fludarabine Phosphate for Injection recall: Sterility Concern
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…
Why was Fludarabine Phosphate for Injection recalled?
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot# 31327913C, Exp. Date 10/2022
- Product
- 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…
- Recalling firm
- Custopharm, Inc.
- Quantity
- 19,384 vials
- Distribution
- Distributed Nationwide in the USA
- Recall date
- September 1, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)