Ophthalmic Solution Recalled

Apotex Corp is recalling 6 lots of brimonidine tartrate ophthalmic solution due to a lack of sterility assurance. According to the March 15, 2023, US Food and Drug Administration (FDA) Enforcement Report, cracks have developed in some of the bottle caps, which could compromise the product’s sterility.

The recall affects the following products, which were manufactured for Apotex Corp, Weston, Florida, by Apotex Inc, Toronto, Ontario, Canada, and distributed throughout the United States between April 5, 2022, and February 22, 2023:

• brimonidine tartrate ophthalmic solution 0.15%, 5-mL dropper bottles (NDC 60505-0564-1, UPC 3 60505 05641 5), from lots TJ9848 (Exp. 2/24), TJ9849 (Exp. 2/24), TK0258 (Exp. 4/24), and TK5341 (Exp. 4/24);
• brimonidine tartrate ophthalmic solution 0.15%, 10-mL dropper bottles (NDC 60505-0564-2, UPC 3 60505 05642 2), from lot TK0261 (Exp. 4/24); and
• brimonidine tartrate ophthalmic solution 0.15%, 15-mL dropper bottles (NDC 60505-0564-3, UPC 3 60505 05643 9), from lot TK0262 (Exp. 4/24).

Apotex Corp voluntarily initiated the recall March 1, 2023. On March 3, 2023, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

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.