Apotex Corp. has initiated a voluntary recall at the consumer level for 6 lots of brimonidine tartrate ophthalmic solution, 0.15%, distributed nationwide in the United States between April 5, 2022 to February 22, 2023 with the guidance of the US FDA.
Brimonidine tartrate ophthalmic solution is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
This recall is being initiated out of an abundance of caution due to cracks that have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility and if so, the possibility of adverse events.
The six (6) lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% can be identified by NDC numbers stated on the carton and label of the product. The lot number and expiry date are located on the top flap of the carton and to the left side of the product description on the bottle label beside the barcode. These lots were distributed nationwide in the USA between April 05, 2022 to February 22, 2023.
Apotex Corp. is notifying all impacted direct accounts (wholesalers, distributors, warehousing chains, mail order pharmacies, and long-term care pharmacies) via email and mail, and arranging for the return of all recalled products.
Patients who have received the identified lots or have questions regarding this recall should contact their pharmacy, as well as immediately contact their healthcare provider for medical advice and return the identified lots to Inmar Rx Solutions by calling 1-855-275-1273 (9:00am – 5:00pm, EST Monday through Friday).
Consumers who have questions regarding this recall can contact Apotex Corp. by phone at 1-800-706-5575 between 8:30 am to 5:00 pm EST Monday through Friday or by email at UScustomerservice@Apotex.com. If consumers have experienced any problems related to taking or using this drug product, they should contact their physician or healthcare provider.