D-0336-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 20, 2019
- Initiation Date
- October 15, 2019
- Termination Date
- December 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42 vials
Product Description
Viatrexx-Prolo, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0558, NDC 73069-443-41.
Reason for Recall
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Distribution Pattern
Distributed to physicians Nationwide throughout the United States and Puerto Rico.
Code Information
Lot Numbers: 19-S00016, Exp. May: 2020