April 2019 FDA Recall Volumex by Iso-tex Diagnostics, Inc
D-1136-2019 - Lack of Assurance of Sterility
This Class II drug recall was voluntarily initiated by Iso-tex Diagnostics, Inc on April 15, 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-1136-2019
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
04-15-2019
04-24-2019
54 1ml syringes
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
TN
12-15-2020
Product Description About Product Description
Full technical description of the product.
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: V191004-927 Exp. 05/10/19
