Drug product
THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
D-0140-2021
Product summary
- Event
- Event 86799
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3 vials
- Official record key
drug-enforcement:D-0140-2021
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 #1110202005, Exp 12/10/2020; Lot #1102202015, Exp 12/08/2020; Lot #1105202009, Exp 12/20/2020
Distribution pattern: CA, CO, FL, IN, KY, OH, TX
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility