Volumex Injection, Solution
FDA Recall NDC 50914-7720
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Volumex (NDC 50914-7720). A significant event, classified as Class II, was initiated on Apr 15, 2019 by Iso-tex Diagnostics, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Apr 15, 2019
Apr 24, 2019
54 1ml syringes
Recall Profile & Regulatory Data
Event ID
82652
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Iso-Tex Diagnostics, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
TN
Termination Date
Dec 15, 2020
Product Description
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
Affected Packages Involved in this Recall
50914-7720-8Product
Class II Terminated
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Mar 11, 2019
Mar 27, 2019
54 syringes
Recall Profile & Regulatory Data
Event ID
82397
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Iso-Tex Diagnostics, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
TN
Termination Date
Dec 15, 2020
Product Description
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
50914-7720-8Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
