Reported Sep 1, 2021 · Terminated
FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals…
Custopharm, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Custopharm, Inc. · 2325 Camino Vida Roble · Carlsbad, CA · 92011-1567
Is this the product you have?
- FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only
- Mfd for
Leucadia Pharmaceuticals CarlsbadCA 92011 U.S.ANDC 24201-237-01
- Lot codes and dates
Lot# 31327913CExp. Date 10/2022
- Amount recalled
- 19,384 vials
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Custopharm, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.