Drug product
Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. East Windsor, NJ 08520, NDC 72189-076-05
D-0637-2022
Product summary
- Firm
- Direct Rx
- Event
- Event 89642
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44 bottles
- Official record key
drug-enforcement:D-0637-2022
Official wording
Reason: Failed impurities/degradation specifications
Code information: Lot#: 18JA2218 Exp. 6/30/23; 20DE2104 Exp. 6/30/23; 08NO2111 Exp. 6/30/23
Distribution pattern: Florida
Derived failure modes
-
Potency or specification failure
Failed impurities/degradation specifications