Alvin, TX, United States
Iso-Tex Diagnostics, Inc recalls
2 recalls recorded since 2018, most recently on 15 April 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 15 April 2019
- Terminated
- 15 December 2020
- Reason
- Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
- Distribution
- TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1136-2019
- 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.
Terminated Class II Drugs
- Recall started
- 11 March 2019
- Terminated
- 15 December 2020
- Reason
- Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
- Distribution
- TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1008-2019
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.