Drug 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.
D-1136-2019
Product summary
- Event
- Event 82652
- Status
- Terminated
- Classification
- Class II
- Quantity
- 54 1ml syringes
- Official record key
drug-enforcement:D-1136-2019
Official wording
Reason: Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Code information: Lot: V191004-927 Exp. 05/10/19
Distribution pattern: TN
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility