Drug product
Testosterone Cypionate/Enanthate/Propionate 80/80/40mg, a) 5 mL-vial, b) 10 ml-vial, Room temperature, Tailor Made Compounding
D-1235-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 246 vials
- Official record key
drug-enforcement:D-1235-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch#: a) 10202107A1, Exp 4/18/2022; b) 10142120A2, Exp 4/12/2022; 10272102A1, Exp 4/25/2022 ; 11032117A2, 11102104A2, Exp 4/30/2022; 01252212A2 , Exp 7/24/2022; 02182227A1, Exp 8/17/2022 .
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility