Class II
Terminated
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.
- Company
- Iso-Tex Diagnostics, Inc
- Recall Initiated
- April 15, 2019
- Posted
- April 24, 2019
- Recall Number
- D-1136-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 54 1ml syringes
- Firm Location
- Alvin, TX, United States
Reason for Recall
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Distribution
TN
Lot / Code Info
Lot: V191004-927 Exp. 05/10/19
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