Drug product
Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine (10%) 0.66ml, Ketorolac (0.5%) 0.33ml, Ofloxacin (0.3) 0.67ml, 2ml vial, Rx, Vital Care Compounder, Hattiesburg, MS
D-1542-2016
Product summary
- Event
- Event 75164
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 vials
- Official record key
drug-enforcement:D-1542-2016
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot# 397267, Use by 9/20/16
Distribution pattern: MS
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility