March 2019 FDA Recall Volumex by Iso-tex Diagnostics, Inc
D-1008-2019 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Iso-tex Diagnostics, Inc on March 11, 2019 for the product Volumex. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in TN and the recall is currently terminated.

Recall Number: D-1008-2019

Reason for Recall
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Initiated
03-11-2019
Reported
03-27-2019
Quantity
54 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82397
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Iso-Tex Diagnostics, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
TN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-15-2020
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# Lot: V190603-922, Exp. 04/05/19

Affected Packages Involved in this Recall

50914-7720-8 Volumex