Drug product
TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 5 ML Formula ID 115678; b) 10 ML Formula ID 115498, APS Pharmacy
D-0732-2022
Product summary
- Event
- Event 89808
- Status
- Terminated
- Classification
- Class II
- Quantity
- 620 vials
- Official record key
drug-enforcement:D-0732-2022
Official wording
Reason: Lack of sterility assurance.
Code information: Lots: a)746000 BUD: 6/26/2022; b) 751472 BUD: 7/20/2022
Distribution pattern: Nationwide in the USA including Puerto Rico.
Derived failure modes
-
Sterility assurance
Lack of sterility