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.

FDA recall notice · announced April 24, 2019 · Iso-tex Diagnostics

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

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.

Reason for recall

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

Notes

Distribution: TN
Lot/code information: Lot: V191004-927 Exp. 05/10/19
Quantity: 54 1ml syringes
Status: Terminated
Products in this recall event:
- 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. (D-1136-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.