Drug product
Testosterone Cypionate/Propionate 180/20mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temperature, Tailor Made Compounding
D-1236-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 176 vials
- Official record key
drug-enforcement:D-1236-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch#: a)11042102A1, Exp 4/30/2022; 12072135A1, Exp 6/5/2022, 01142228A1, Exp 7/13/2022; 02182231A1, Exp 8/17/2022; b)11042102A1, Exp 4/30/2022; 01142228A1, Exp 7/13/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility