Drug product
C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 63323-0010-02.
D-1076-2020
Product summary
- Event
- Event 85217
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 bags
- Official record key
drug-enforcement:D-1076-2020
Official wording
Reason: Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Code information: Lot: 03022020@3 BUD: 03/16/2020
Distribution pattern: Specific prescriptions to patients in TN
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility