Drug product
Olopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, Hattiesburg, MS
D-1546-2016
Product summary
- Event
- Event 75164
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1546-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot# 389278, Use by 8-9-16
Distribution pattern: MS
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility