Lumigan Solution/ Drops
FDA Recall NDC 0023-3205
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 Lumigan (NDC 0023-3205). A significant event, classified as Class III, was initiated on Oct 19, 2017 by Allergan, Inc.. 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
October 2017 Class III Recall: Failed Impurities/Degradation Specifications.
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications.
Oct 19, 2017
Nov 22, 2017
153,616 bottles
Recall Profile & Regulatory Data
Event ID
78325
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Allergan Sales, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago.
Termination Date
Oct 30, 2019
Product Description
Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03
Batch or Lot Expiration Information
Lot# : 92575 Exp. JUN-2018
Affected Packages Involved in this Recall
0023-3205-02Product
0023-3205-03Product
0023-3205-05Product
0023-3205-08Product
Class III Terminated
Failed Impurities/Degradation Specifications
Mar 16, 2017
Apr 19, 2017
56,878 bottles
Recall Profile & Regulatory Data
Event ID
76748
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Allergan Sales, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
May 01, 2019
Product Description
Lumigan (bimatoprost ophthalmic solution) 0.01%, 7.5 mL bottle, Rx only, Allergan Irvine, CA 92612, NDC 0023-3205-08.
Batch or Lot Expiration Information
Lot# : 92577, Exp. JUN 2018
Affected Packages Involved in this Recall
0023-3205-02Product
0023-3205-03Product
0023-3205-05Product
0023-3205-08Product
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.
