Drug product
TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 533-8800
D-0772-2020
Product summary
- Event
- Event 84546
- Status
- Terminated
- Classification
- Class II
- Quantity
- 166 vials
- Official record key
drug-enforcement:D-0772-2020
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 09122019@9 Exp. 03/10/2020; 09242019@9 Exp. 03/22/2020; 09192019@20 Exp. 03/17/2020; 10032019@8 Exp. 03/31/2020; 10032019@11 Exp. 03/31/2020; 10182019@5 Exp. 04/15/2020; 10242019@7 Exp. 04/21/2020; 10232019@24 Exp. 04/20/2020; 11042019@12 Exp. 05/02/2020; 11212019@3 Exp. 05/19/2020; 11212019@2 Exp. 05/19/2020; 11042019@15 Exp. 05/02/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of sterility