Drug product
S-BENZALKONIUM CHLORIDE 0.013% SOLUTION, 1000ml plastic container, For irrigation use only, Rx only, Red Mountain Compounding Rx.
D-0205-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4x1000 plastic containers
- Official record key
drug-enforcement:D-0205-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S03142019DT@09, Exp 9/14/19; S05052019DH@04, Exp 11/5/19; S06192019DT@03, Exp 12/19/19; S06262019DT@12, Exp 12/26/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility