Drug product
TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 4 ML Formula ID 115387; b) (RM) 10 ML Formula ID 115125; APS Pharmacy
D-0730-2022
Product summary
- Event
- Event 89808
- Status
- Terminated
- Classification
- Class II
- Quantity
- 846 vials
- Official record key
drug-enforcement:D-0730-2022
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: a) 745383 BUD: 6/20/2022; 759295 BUD: 8/30/2022; b) 745749 BUD: 6/21/2022; 746272 BUD: 6/27/2022
Distribution pattern: Nationwide in the USA including Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of sterility