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-1008-2019
Product summary
- Event
- Event 82397
- Status
- Terminated
- Classification
- Class II
- Quantity
- 54 syringes
- Official record key
drug-enforcement:D-1008-2019
Official wording
Reason: Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Code information: Lot: V190603-922, Exp. 04/05/19
Distribution pattern: TN
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility