Moxifloxacin Solution/ Drops
FDA Recall NDC 65862-840
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Moxifloxacin (NDC 65862-840). A significant event, classified as Class II, was initiated on Jan 14, 2022 by Aurobindo Pharma Limited. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
January 2022 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications
Jan 14, 2022
Feb 23, 2022
115776 bottles
Recall Profile & Regulatory Data
Event ID
89423
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Jul 31, 2024
Product Description
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
Batch or Lot Expiration Information
Lot# : CMF210001, CMF210003, CMF210004, Exp 6/2023
Affected Packages Involved in this Recall
65862-840-03Product
Class III Terminated
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Dec 02, 2019
Jan 22, 2020
100,080 bottles
Recall Profile & Regulatory Data
Event ID
84498
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
AuroMedics Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the U.S.
Termination Date
Nov 22, 2022
Product Description
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.
Batch or Lot Expiration Information
Lot# s: CMF190008; CMF190009, Exp. 04/2021; CMF190025; CMF190026, Exp. 06/2021.
Affected Packages Involved in this Recall
65862-840-03Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
