Volumex — Class II drug recall D-1136-2019
Terminated recall by Iso-Tex Diagnostics, Inc, reported 2019-04-24, distributed in TN. Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be
| Recall number | D-1136-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Iso-Tex Diagnostics, Inc, Alvin, TX, United States |
| Recall initiated | 2019-04-15 |
| Classified | 2019-04-18 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2020-12-15 |
| Distributed | TN |
| Quantity | 54 |
| Reason classes | sterility |
| NDC | 50914-7720, 50914-7720-08 |
| Lot numbers | V191004-927 |
| Expiration dates | 2019-05-10 |
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.
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-1136-2019. 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.