Safety Report: Apotex Brimonidine Tartrate Ophthalmic Solution, 0.15% - recalled due to lack of sterility, USA

United States

Apotex Corp., with the knowledge of the US FDA, is initiating a voluntary recall at the Consumer level for six (6) lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% specified below. 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. These lots were distributed nationwide in the USA between April 05, 2022 to February 22, 2023.

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. 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.

-Affected products:

Product: Brimonidine Tartrate Ophthalmic Solution
Strength: 0.15%
Pack Size: 5 mL
NDC #: 60505-0564-1
UPC Code on Carton: 360505056415
UPC Code on Bottle: (01)0(03) 60505056415
Lot #: TJ9848 Expiry Date: 02/2024
Lot #: TJ9849 Expiry Date: 02/2024
Lot #: TK0258 Expiry Date: 04/2024
Lot #: TK5341 Expiry Date: 04/2024

Product: Brimonidine Tartrate Ophthalmic Solution
Strength: 0.15%
Pack Size: 10 mL
NDC #: 60505-0564-2
UPC Code on Carton: 360505056422
UPC Code on Bottle: (01)0(03) 60505056422
Lot #: TK0261 Expiry Date: 04/2024

Product: Brimonidine Tartrate Ophthalmic Solution
Strength: 0.15%
Pack Size: 15 mL
NDC #: 60505-0564-3
UPC Code on Carton: 360505056439
UPC Code on Bottle: (01)0(03) 60505056439
Lot # TK0262 Expiry Date: 04/2024

Patients who have received the identified lots or have questions regarding this recall should contact their pharmacy. They should immediately contact their health care provider for medical advice and return the identified lots to Inmar Rx Solutions.

Wholesalers, Distributors, Warehousing Chains, Mail Order Pharmacy and Long-Term Care Pharmacy should return the recalled product to the place of purchase. Anyone with an existing inventory of the recalled product should quarantine the recalled lots immediately.

In case you experienced harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Apotex Corp.
Brand name: Apotex
Product recalled: Brimonidine Tartrate Ophthalmic Solution, 0.15%
Reason of the recall: Potential lack of sterility.
FDA Recall date: March 02, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-brimonidine-tartrate-ophthalmic-solution-015-due