Moxifloxacin Solution/ Drops
FDA Recall NDC 68180-422
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Moxifloxacin (NDC 68180-422). A significant event, classified as Class III, was initiated on Feb 26, 2019 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities."
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
February 2019 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
Feb 26, 2019
Mar 06, 2019
674,628 bottles
Recall Profile & Regulatory Data
Event ID
82249
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Termination Date
Jun 22, 2020
Product Description
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01.
Batch or Lot Expiration Information
Lot# Lots: H701618, H701619, H701620, Exp March 2019; H702220, H702221, H702222, H702223, H702224, H702225, H702351, Exp April 2019; H702971, H702972, H702973, H702974, H703151, H703152, H703153, Exp June 2019; H703155, H703682, H703683, Exp July 2019; H704243, H704245, H704247, Exp September 2019; H704707, H704709, H705038, H705039, Exp October 2019; H705561, Exp November 2019; H800394, H800395, H800617, H800618, Exp January 2020; H801585, H801586, H801721, H801722, Exp March 2020; H802138, H802139, H802140, Exp April 2020; H802421, H802707, H802718, Exp May 2020; H803187, H803188, H803232, Exp June 2020; H803749, H803750, Exp July 2020; H804326, H804327, H804328, H804330, H804549, H804552, H804630, H804632, Exp September 2020; H805163, H805361, H805362, H805676, Exp November 2020; H805690, H805692, H805694, Exp December 2020
Affected Packages Involved in this Recall
68180-422-01Product
February 2019 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
Feb 01, 2019
Feb 20, 2019
43,860 3ml bottles
Recall Profile & Regulatory Data
Event ID
82037
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed by 5 wholesalers, 6 drug chains, 4 mail order pharmacies and 1 mail order pharmacy/supermarket who may have further distribute the product throughout the United States.
Termination Date
Jun 26, 2020
Product Description
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 Manufactured by: lupin Limited Pithampur (M.P.) 454 775 India. NDC 68180-422-01
Batch or Lot Expiration Information
Lot# Lot Numbers: H705562, H705563, EXP. 11/2019; H800616, EXP. 01/2020
Affected Packages Involved in this Recall
68180-422-01Product
Class III Terminated
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Jul 26, 2018
Aug 08, 2018
13,896 bottles
Recall Profile & Regulatory Data
Event ID
80668
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States
Termination Date
Dec 06, 2019
Product Description
Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01
Batch or Lot Expiration Information
Lot# : H800393, Exp. 01/2020
Affected Packages Involved in this Recall
68180-422-01Product
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.
