FDAFDA · Food and drugs·Recall number D-1008-2019
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 March 27, 2019 · Recall initiated: March 11, 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: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- VOLUMEX
- Manufacturer
- Iso-Tex Diagnostics, Inc
- Distributor
- TN
- Lot
- Lot: V190603-922, Exp. 04/05/19
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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