Drug product
MITOMYCIN 0.04% (PF) OPH SOLN, 1ML per syringe, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0917-01
D-1684-2019
Product summary
- Event
- Event 83074
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1684-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: All lots within expiry
Distribution pattern: Nationwide USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility