Drug product
Moxifloxacin Ophthalmic Solution, 0.5%, 3 mL, Rx Only, Packaged and Distributed By: Direct Rx, LLC 94 Worldwide Drive, Dawsonville, GA 30534, NDC 72189-0334-05
D-0101-2023
Product summary
- Firm
- Direct Rx
- Event
- Event 91114
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 bottles
- Official record key
drug-enforcement:D-0101-2023
Official wording
Reason: cGMP deviation: discontinue of stability support for product.
Code information: Lot #: 07MA2232, Exp. 4/30/23
Distribution pattern: FL
Derived failure modes
-
Manufacturing or process control
cGMP deviation