Drug product
Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial, New Vitalis Pharmacy
D-0523-2020
Product summary
- Event
- Event 84189
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2981.62 mL
- Official record key
drug-enforcement:D-0523-2020
Official wording
Reason: Lack of sterility assurance.
Code information: Lot, expiry: AL-07232019@99, exp 9-23-2019; AL-07312019@99, exp 9-30-2019; AL-08132019@99, exp 10-13-2019; AL-08272019@901, exp 10-27-2019; AL-08282019@909, exp 10-28-2019; Al-09032019@903, exp 11-3-2019
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of sterility