Drug product
FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
D-0129-2021
Product summary
- Event
- Event 86799
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 vial
- Official record key
drug-enforcement:D-0129-2021
Official wording
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Code information: Lot #1112202006, Exp 12/12/2020
Distribution pattern: CA, CO, FL, IN, KY, OH, TX
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility