Multi event Drug Recall Enforcement Report Class III voluntary initiated by Allergan Sales, LLC, originally initiated on 10-19-2017 for the product 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.. The product was recalled due to failed impurities/degradation specifications.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0077-2018 | 10-19-2017 | 11-22-2017 | Class III | 715,041 bottles | 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.. | Failed Impurities/Degradation Specifications. | Terminated |
| D-0078-2018 | 10-19-2017 | 11-22-2017 | Class III | 153,616 bottles | Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03 | Failed Impurities/Degradation Specifications. | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 0023-3205 | Lumigan | Bimatoprost | Solution/ Drops | Ophthalmic | Allergan, Inc. | Human Prescription Drug |
| 0023-9211 | Combigan | Brimonidine Tartrate, Timolol Maleate | Solution/ Drops | Ophthalmic | Allergan, Inc. | Human Prescription Drug |
