FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceutical
Summary
The FDA issued a Class II for FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx O by Custopharm, Inc.. Reason: Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing..
Details
Source
Drug Recall
External ID
D-0765-2021
Action Date
2021-09-01
Status
Terminated
Category
drug
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
Lot/Code Info: Lot# 31327913C, Exp. Date 10/2022
Quantity Affected: 19,384 vials
Reason for Recall
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
Distribution
Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-30
Company
Carlsbad, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 58 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Custopharm, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Custopharm, Inc. have FDA actions?
This is the only FDA action we have on record for Custopharm, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0765-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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