Drug product
TESTOSTERONE CYP 200MG/ML OIL (SESAME) INJ in 10 mL vial Assurance Infusion (713) 533-8800
D-0771-2020
Product summary
- Event
- Event 84546
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 vials
- Official record key
drug-enforcement:D-0771-2020
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 08212019@17 Exp. 02/17/2020; 10232019@23 Exp. 04/20/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of sterility