Apotex Corp. issues voluntary nationwide recall of brimonidine tartrate ophthalmic solution, 0.15%

Brimonidine tartrate ophthalmic solution is an alpha-adrenergic receptor agonist indicated for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension. (Image Credit: Adobe Stock/Towfiqu Barbhuiya)

Apotex Corp. is initiating a voluntary recall at the consumer level for 6 lots of brimonidine tartrate ophthalmic solution, 0.15%.

According to a release from the U.S. Food and Drug Administration (FDA),¹ the recall is 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.

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.

According to the FDA, the 6 lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% that have been recalled 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. (Figure 1)

Figure 1: The lots affected by the voluntary recall. (Image courtesy U.S. Food and Drug Administration)

Apotex Corp. has notified all impacted direct accounts, including wholesalers and distributors, of this voluntary recall and is arranging for the return of the recalled product.

According to the FDA, any patients who have received the lots identified in the recall should immediately contact their health care provider for medical advice and return the product to Inmar RX Solutions.

Consumers with the impacted units of Brimonidine Tartrate Ophthalmic Solution, 0.15%, can contact Inmar Rx Solutions at 1-855-275-1273, to receive a recall/return packet including the Recall Stock Response Form.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration

References:

1. Apotex Corp. Issues Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15% Due to Cracks that Have Developed in Some of the Units Caps of the Bottles. Press release. U.S. FDA; March 2, 2022. Accessed March 6, 2023. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-brimonidine-tartrate-ophthalmic-solution-015-due