Drug product
Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For Topical Ophthalmic Use Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03.
D-0789-2020
Product summary
- Event
- Event 84498
- Status
- Terminated
- Classification
- Class III
- Quantity
- 100,080 bottles
- Official record key
drug-enforcement:D-0789-2020
Official wording
Reason: Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Code information: Lot #s: CMF190008; CMF190009, Exp. 04/2021; CMF190025; CMF190026, Exp. 06/2021.
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Unknown
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.