Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15%

Apotex is issuing a voluntary recall at the consumer level for six lots of Brimonidine Tartrate Ophthalmic Solution, 0.15%, specified below. The recall is being initiated due to cracks that have developed in some of the unit caps of Brimonidine Tartrate Ophthalmic Solution bottles. The broken caps may impact sterility and the possibility of adverse events.

Brimonidine Tartrate Ophthalmic Solution is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

The six lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% can be identified by national drug code numbers stated on the carton and the label of each product. One can find the lot number and expiry date located on the top flap of the carton and to the left side of the product description on the bottle label beside the barcode. The lots were distributed across the United States between April 5, 2022 and Feb. 22, 2023.

Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.

Source: FDA