Drug product
Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35.
D-0251-2018
Product summary
- Event
- Event 78928
- Status
- Terminated
- Classification
- Class II
- Quantity
- 193 vials
- Official record key
drug-enforcement:D-0251-2018
Official wording
Reason: Labeling: Label Error on Declared Strength
Code information: Lot: MIT100217SVDS BUD: 03/01/2018
Distribution pattern: Nationwide.
Derived failure modes
-
Labeling or packaging
Labeling: Label Error