The Recall Desk
SevereFDA (Drugs)·D-1008-2019·Announced 2019-03-27

FDA Recalls Volumex Iodinated I-131 Albumin Due to Sterility Concerns

Iso-Tex Diagnostics is recalling 54 syringes of Volumex (Iodinated I-131 Albumin) because environmental monitoring results exceeded limits, meaning sterility cannot be assured.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for serious adverse health consequences (such as sterility failure in an injectable drug) are categorized as Severe (Score 4), especially when no specific hospitalization reports are explicitly detailed in the provided text but the risk is significant.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Volumex (Iodinated I-131 Albumin) Injection USP. The product is manufactured by Iso-Tex Diagnostics, Inc. for Daxor Corp. The recall involves 54 syringes, each containing 25 uCi per 1 mL, with NDC 50914-7720-8. The specific lot number is V190603-922, and the expiration date is 04/05/19.

The reason for the recall is a lack of assurance of sterility. Preliminary environmental monitoring reports indicated that limits were exceeded, which means the sterility of the product cannot be guaranteed. This is a prescription-only drug intended for intravenous use.

The distribution pattern is listed as TN (Tennessee). Healthcare providers and patients who have received this specific lot of Volumex should contact their healthcare provider or the recalling firm for further instructions. Consumers should not use the product if they have questions about its sterility or safety.

The recalled product

Product
VOLUMEX (IODINATED I-131 ALBUMIN)
Brand
VOLUMEX
Manufacturer
Iso-Tex Diagnostics, Inc
Category
Drug — Radiopharmaceutical
Hazard
Affected units
54

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: V190603-922
  • Exp. 04/05/19

Distribution

Distributed in 1 state:

Related recalls

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Same hazard · sterility failure

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