Drug product
GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy
D-0728-2022
Product summary
- Event
- Event 89808
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6017 vials
- Official record key
drug-enforcement:D-0728-2022
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 745708 BUD: 6/21/2022; 753364 BUD: 7/27/2022; 752508 BUD: 7/24/2022; 750313 BUD: 7/16/2022; 753020 BUD: 7/26/2022; 747712 BUD: 7/4/2022; 747974 BUD: 7/5/2022; 754802 BUD: 8/3/2022; 751158 BUD: 7/19/2022; 756837 BUD: 8/16/2022; 748939 BUD: 7/10/2022; 750842 BUD: 7/18/2022; 755742 BUD: 8/8/2022; 758691 BUD: 8/28/2022; 758432 BUD: 8/27/2022; 758975 BUD: 8/29/2022; 756643 BUD: 8/15/2022
Distribution pattern: Nationwide in the USA including Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of sterility