Drug product
TESTOSTERONE CYPIONATE 200mg/ml, 1ML MDV, Vital Care Compounder, Hattiesburg, MS
D-1166-2016
Product summary
- Event
- Event 74591
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 units
- Official record key
drug-enforcement:D-1166-2016
Official wording
Reason: Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vial on all containers.
Code information: Lot#:382331, Use by 12-11-16
Distribution pattern: MS
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility