Volumex — Class II drug recall D-1008-2019
Terminated recall by Iso-Tex Diagnostics, Inc, reported 2019-03-27, distributed in TN. Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterilit
| Recall number | D-1008-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Iso-Tex Diagnostics, Inc, Alvin, TX, United States |
| Recall initiated | 2019-03-11 |
| Classified | 2019-03-18 |
| Reported by FDA | 2019-03-27 |
| Terminated | 2020-12-15 |
| Distributed | TN |
| Quantity | 54 syringes |
| Reason classes | sterility |
| NDC | 50914-7720, 50914-7720-08 |
| Lot numbers | V190603-922 |
| Expiration dates | 2019-04-05 |
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: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1008-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.