Fludarabine Phosphate Injection Recalled Due to Sterility Concern
Custopharm, Inc. is recalling Fludarabine Phosphate for Injection, USP 50 mg because the manufacturer detected microbial contamination during environmental monitoring in aseptic manufacturing areas, raising sterility assurance concerns.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is FDA Class II for a sterility defect in an injectable drug. Although no illnesses or injuries are reported in the source text, a compromised sterility assurance in an intravenous chemotherapy agent (fludarabine is used to treat hematologic malignancies) poses significant risk of serious infection. Class II classification with a high-risk injectable product warrants a Severe rating.
Plain-English summary
Custopharm, Inc. is recalling Fludarabine Phosphate for Injection, USP 50 mg per vial (NDC 24201-237-01, Lot# 31327913C, Expiration Date 10/2022) due to a lack of assurance of sterility.
The recall was initiated because the manufacturing firm detected microbial recoveries during environmental monitoring in aseptic areas of the manufacturing facility. This finding indicates a potential breach in the sterility assurance process for the affected lot.
The recalled product was distributed nationwide in the USA. Patients receiving this product should contact their healthcare provider or pharmacist for guidance regarding their treatment. Healthcare providers should verify whether they dispensed this specific lot and should not administer any units from Lot# 31327913C.
The recalled product
- 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 24201-237-01
- Manufacturer
- Custopharm, Inc.
- Category
- Drug — Injectable / Oncology
- Affected units
- 19,384
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# 31327913C
- Exp. Date 10/2022
Distribution
Distributed nationwide across the United States.
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