Drug product
Gonadorelin 100mcg/mL, 10mL per vial, Refrigerate, Tailor Made Compounding
D-1207-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 294 vials
- Official record key
drug-enforcement:D-1207-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch #: 01062225B, Exp 4/6/2022; 01142207A1, Exp 4/14/2022; 02012228A1, Exp 5/2/2022; 02032203A1, Exp 5/4/2022; 03012211A1, Exp 5/30/2022; 03082240A1, Exp 6/6/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility