Drug product
(CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID136345, APS Pharmacy
D-0729-2022
Product summary
- Event
- Event 89808
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1843 vials
- Official record key
drug-enforcement:D-0729-2022
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: 749842 BUD: 7/13/2022; 749568 BUD: 7/12/2022; 752053 BUD: 7/23/2022; 752817 BUD: 7/25/2022; 757404 BUD: 8/21/2022; 757915 BUD: 8/23/2022; 757321 BUD: 8/20/2022; 753718 BUD: 7/30/2022
Distribution pattern: Nationwide in the USA including Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of sterility