Drug product
Testosterone Cypionate (GSO) 100mg/ml a)1mL-vial , b) 2mL-vial, Room temperature, Tailor Made Compounding
D-1230-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 273 vials
- Official record key
drug-enforcement:D-1230-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch#: a) 12212109A2, Exp 6/19/2022; 01312217A1, Exp 7/30/2022; b) 10202108A1, Exp 4/18/2022; 12012125A, Exp 5/30/2022 ;02182230A1, Exp 8/17/2022; 10202108A1; 03022222A1, Exp 8/29/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility