FDA Recalls Volumex Injection Due to Sterility Concerns
Iso-Tex Diagnostics is recalling 54 syringes of Volumex (Iodinated I-131 Albumin) because environmental monitoring results indicate sterility cannot be assured.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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. Per the rubric, FDA Class II recalls involving potential hospitalization or significant injury risks (such as sterility failures in injectable drugs) are categorized as Severe.
Plain-English summary
Iso-Tex Diagnostics, Inc. is recalling 54 syringes of Volumex (Iodinated I-131 Albumin) Injection USP, 25 uCi per 1 mL. The product is a prescription-only radiopharmaceutical manufactured for Daxor Corp. The specific lot affected is V191004-927, with an expiration date of 05/10/19. The product was distributed in Tennessee.
The recall was initiated due to a lack of assurance of sterility. Environmental monitoring reports exceeded established limits, meaning the manufacturer cannot guarantee that the product is sterile. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients who have received this specific lot of Volumex should contact their healthcare provider for guidance. Consumers should not use the product if they have it in their possession and should follow instructions from their medical provider regarding disposal or return.
The recalled product
- Product
- VOLUMEX (IODINATED I-131 ALBUMIN)
- Brand
- VOLUMEX
- Manufacturer
- Iso-Tex Diagnostics, Inc
- Category
- Drug — Radiopharmaceutical
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 (1)
- Lot: V191004-927 Exp. 05/10/19
Distribution
Distributed in 1 state:
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