Drug product
Viatrexx-MuSkel-Neural, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC4020, NDC 73069-347-41.
D-0327-2020
Product summary
- Event
- Event 84055
- Status
- Terminated
- Classification
- Class II
- Quantity
- 61 vials
- Official record key
drug-enforcement:D-0327-2020
Official wording
Reason: Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Code information: Lot Numbers: 19-S00002, Exp. May: 2020
Distribution pattern: Distributed to physicians Nationwide throughout the United States and Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility