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.
Reported: April 24, 2019 Initiated: April 15, 2019 #D-1136-2019
Product Description
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.
Details
- Recalling Firm
- Iso-Tex Diagnostics, Inc
- Units Affected
- 54 1ml syringes
- Distribution
- TN
- Location
- Alvin, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Iso-Tex Diagnostics, Inc. Units affected: 54 1ml syringes.
Why was this product recalled? ▼
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 24, 2019. Severity: Moderate. Recall number: D-1136-2019.
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