Drug product
BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
D-0132-2021
Product summary
- Event
- Event 86799
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 vials
- Official record key
drug-enforcement:D-0132-2021
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 #1102202009, Exp 12/08/2020; Lot #1105202009, Exp 12/20/2020; Lot #1110202001, Exp 12/15/2020; Lot #1112202004, Exp 12/12/2020
Distribution pattern: CA, CO, FL, IN, KY, OH, TX
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility