Iso-Tex Diagnostics Volumex Injection Recall: FDA Class II

Why it was recalled

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

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.

Lot numbers, UPCs & expiration codes

Lot: V191004-927 Exp. 05/10/19

Where it was sold

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1136-2019
Classification: Class II
Status: Terminated
Recall initiated: Apr 15, 2019
FDA report date: Apr 24, 2019
Quantity: 54 1ml syringes
Recall type: Voluntary: Firm initiated
Recalling firm: Iso-Tex Diagnostics, Inc

Original FDA data

Every field from FDA enforcement report D-1136-2019, exactly as published.

Show all FDA fields

City: Alvin
State: TX
Status: Terminated
Country: United States
Event ID: 82652
Address: 1511 County Road 129
Code information: Lot: V191004-927 Exp. 05/10/19
Postal code: 77511-1466
Report date: Apr 24, 2019
Product type: Drugs
Recall number: D-1136-2019
Classification: Class II
Recalling firm: Iso-Tex Diagnostics, Inc
Product quantity: 54 1ml syringes
Termination date: Dec 15, 2020
Reason for recall: Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Voluntary / mandated: Voluntary: Firm initiated
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.
Distribution pattern: TN
Recall initiation date: Apr 15, 2019
Initial firm notification: E-Mail
Center classification date: Apr 18, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1136-2019, published Apr 24, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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Iso-Tex Diagnostics Volumex Recall

Summary