Drug product
Testosterone Enanthate (GSO) 100mg/ml, 2 mL-vial, Room temperature, Tailor Made Compounding
D-1237-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 93 vials
- Official record key
drug-enforcement:D-1237-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch#: 11102106A1, Exp 4/30/2022; 01142230A1, Exp 7/13/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility