D-1008-2019 Class II Terminated
FDA drug recall D-1008-2019 was initiated by Iso-Tex Diagnostics, Inc on March 11, 2019 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured. The recall status is terminated (terminated December 15, 2020). Affected quantity: 54 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- March 27, 2019
- Initiation Date
- March 11, 2019
- Termination Date
- December 15, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 54 syringes
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: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Distribution Pattern
TN
Code Information
Lot: V190603-922, Exp. 04/05/19