Drug product
S-GENTAMICIN 480MG/1L, IRRIGATION SOLN, 1000ML plastic bottle, Red Mountain Compounding Pharmacy
D-0222-2020
Product summary
- Event
- Event 83669
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 1L- bottles
- Official record key
drug-enforcement:D-0222-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: S07092019DT@18, Exp 8/23/19; S07312019DH@08, Exp 10/14/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility