Drug product
Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a) 4 mL-vial, b)10mL-vial, Room temperature, Tailor Made Compounding
D-1233-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 106 vials
- Official record key
drug-enforcement:D-1233-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch#: a)10142123A2, Exp 4/12/2022, 02042202A1, Exp 8/3/2022; b) 10142121A2, Exp 4/12/2022; 10202105A1, Exp 4/18/2022; 11102102A1, Exp 4/30/2022; 02042202A1, Exp 8/3/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility