Reported Mar 27, 2019 · Terminated
Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY,…
Iso-Tex Diagnostics, 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: Iso-Tex Diagnostics, Inc · 1511 County Road 129 · Alvin, TX · 77511-1466
Is this the product you have?
- Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY
- ByIso-Tex Diagnostics, Inc.; NDC 50914-7720-8
- Lot codes and dates
- Lot
V190603-922Exp. 04/05/19
- Lot
- Amount recalled
- 54 syringes
Where it was sold
Why it was recalled
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
This product could cause temporary or reversible health problems — stop using it.
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