Drug product
Testosterone Enanthate (GSO) 200mg/ml, a) 5 mL-vial, b) 10 mL-vial, Room temperature, Tailor Made Compounding
D-1238-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 414 vials
- Official record key
drug-enforcement:D-1238-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch#: a)10142117A2, Exp 4/12/2022; 10272108A1, Exp 4/25/2022; 11302113A2, Exp 5/29/2022; 02252220A1, Exp 8/24/2022; b)10142108A2, Exp 4/12/2022; 12072134A1, Exp 6/5/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility