Drug product
Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0097-2020
Product summary
- Event
- Event 83789
- Status
- Terminated
- Classification
- Class II
- Quantity
- 152 cartridges
- Official record key
drug-enforcement:D-0097-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: All lots remaining within expiry.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility