Recalls / Class II
Class IID-1008-2019
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.
- Brand name
- Volumex
- Generic name
- Iodinated I-131 Albumin
- Active ingredient
- Human Serum Albumin I-131
- Route
- Intravenous
- NDC
- 50914-7720
- FDA application
- BLA017837
- Affected lot / code info
- Lot: V190603-922, Exp. 04/05/19
Why it was recalled
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Recalling firm
- Firm
- Iso-Tex Diagnostics, Inc
- Manufacturer
- Iso-Tex Diagnostics, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1511 County Road 129, N/A, Alvin, Texas 77511-1466
Distribution
- Quantity
- 54 syringes
- Distribution pattern
- TN
Timeline
- Recall initiated
- 2019-03-11
- FDA classified
- 2019-03-18
- Posted by FDA
- 2019-03-27
- Terminated
- 2020-12-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1008-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.