FDA recall D-1136-2019

Product

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.

Reason for recall

Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.

Distribution

TN

Key facts

Status

Terminated

Initiation date

2019-04-15

Report date

2019-04-24

Termination date

2020-12-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Alvin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1136-2019