Drug recall D-1136-2019
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.
Lots and codes
Lot: V191004-927 Exp. 05/10/19
Recall details
- Recalling firm
- Iso-Tex Diagnostics, Inc, Alvin, TX
- Quantity
- 54 1ml syringes
- Distribution
- TN
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 15, 2019
- Terminated
- December 15, 2020
Related products
- Volumex – drug information
- NDC 50914-7720 Volumex · Human Serum Albumin I-131 .025 mCi/mL · Iso-Tex Diagnostics, Inc.