FDA Drug recall D-1136-2019
Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY
- FDA Drug
- Class II
- terminated
- Published 2019-04-24
On 2019-04-24 the FDA classified a Class II recall of 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, citing lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1136-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-15 |
| Published | 2019-04-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Iso Tex Diagnostics |
| Distribution | TN |
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
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Identifiers
| ndc | 50914-7720-8 |
|---|---|
| code_info | Lot: V191004-927 Exp. 05/10/19 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1136-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.