Drug product
TESTOSTERONE CYP 200MG/ML OIL in 10 mL vial Assurance Infusion (713) 533-8800
D-0770-2020
Product summary
- Event
- Event 84546
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 vials
- Official record key
drug-enforcement:D-0770-2020
Official wording
Reason: Lack of sterility assurance.
Code information: Lot: 10242019@7 Exp. 04/21/2020; 10032019@11 Exp. 03/31/2020; 11042019@12 Exp. 05/02/2020; 09242019@9 Exp. 03/22/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of sterility