Drug product
TESTOSTERONE CYPIONATE/ ANASTROZOLE *GS* OIL (10ML) 200MG/0.5MG/ML; Packaged in a multi dose 10ML vial, as a) (CA) 4 ML Formula ID 136164; b) (RM) 10 ML Formula ID 115962; APS Phar
D-0731-2022
Product summary
- Event
- Event 89808
- Status
- Terminated
- Classification
- Class II
- Quantity
- 73 vials
- Official record key
drug-enforcement:D-0731-2022
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: a)750851 BUD: 7/18/2022; b) 754549 BUD: 8/2/2022
Distribution pattern: Nationwide in the USA including Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of sterility