Combigan Solution/ Drops
FDA Recall NDC 0023-9211
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 Combigan (NDC 0023-9211). A significant event, classified as Class II, was initiated on Mar 19, 2019 by Allergan, Inc.. The reported reason for this action was: "cGMP Deviations"
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
Class II Terminated
cGMP Deviations
Mar 19, 2019
Apr 03, 2019
72 bottles
Recall Profile & Regulatory Data
Event ID
82424
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Allergan Sales, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
TN only
Termination Date
Apr 29, 2020
Product Description
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% 5 mL bottles, Rx only, Allergan, Inc. Irvine, CA 92612 U.S.A. NDC 0023-9211-05
Batch or Lot Expiration Information
Lot# : 99946 Exp. January 16, 2021
Affected Packages Involved in this Recall
0023-9211-03Product
0023-9211-05Product
0023-9211-10Product
0023-9211-15Product
October 2017 Class III Recall: Failed Impurities/Degradation Specifications.
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications.
Oct 19, 2017
Nov 22, 2017
715,041 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
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03; b) 5 mL (NDC# 0023-9211-05); c) 10 mL (NDC# 0023-9211-10); d) 15 mL (NDC# 0023-9211-15) bottles, Manufactured By: Allergan, Irvine, CA 92612..
Batch or Lot Expiration Information
Lot# : a) 94659 Exp. FEB-2019; b) 94715, Exp. JAN-2019; 94757, Exp. FEB-2019, 94715A, Exp. JAN-2019; 95297, Exp. MAR-2019; c) 95223 Exp. MAR-2019; d) 95220 Exp. MAR-2019
Affected Packages Involved in this Recall
0023-9211-03Product
0023-9211-05Product
0023-9211-10Product
0023-9211-15Product
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.
