Drug product
Testosterone Cypionate/Anastrozole 200mg/0.5mg/mL, 10mL-vial, Room temperature, Tailor Made Compounding
D-1232-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 41 vials
- Official record key
drug-enforcement:D-1232-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch#: 11232117A1, Exp 5/22/2022; 01312215A1, Exp 7/30/2022
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility