Drug product
Trypan Blue 0.3%, 0.5 mL Vial, Vital Care Compounder, Hattiesburg, MS
D-1056-2016
Product summary
- Event
- Event 74539
- Status
- Terminated
- Classification
- Class II
- Quantity
- 54 vials
- Official record key
drug-enforcement:D-1056-2016
Official wording
Reason: Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Code information: Lot#: 391462, Use by 10-06-2016
Distribution pattern: MS
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility