Drug product
Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03
D-0560-2022
Product summary
- Event
- Event 89423
- Status
- Terminated
- Classification
- Class II
- Quantity
- 115776 bottles
- Official record key
drug-enforcement:D-0560-2022
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot#: CMF210001, CMF210003, CMF210004, Exp 6/2023
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications