Drug product
Gentamicin 240 mg/500 mL Sterile Water for Irrigation,60 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
D-1193-2019
Product summary
- Event
- Event 82554
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1193-2019
Official wording
Reason: Lack of sterility assurance.
Code information: All Lots
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of sterility