FDAFDA · Food and drugs·Recall number D-1136-2019
Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8.
Published April 24, 2019 · Recall initiated: April 15, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- VOLUMEX
- Manufacturer
- Iso-Tex Diagnostics, Inc
- Distributor
- TN
- Lot
- Lot: V191004-927 Exp. 05/10/19
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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