Drug product
*Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 67457-0518-05.
D-1077-2020
Product summary
- Event
- Event 85217
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 bottles
- Official record key
drug-enforcement:D-1077-2020
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@5 BUD: 03/16/2020
Distribution pattern: Specific prescriptions to patients in TN
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility