Eye Solution Recalled

FDC Limited is recalling 362 544 bottles of timolol maleate ophthalmic solution distributed by Rising Pharmaceuticals Inc. because of defective containers. According to the August 21, 2024, US Food and Drug Administration (FDA) Enforcement Report, there is the potential for a spike from the product cap to be lodged in the container nozzle.

The recall includes timolol maleate ophthalmic solution, 0.5%, sterile, in 5-mL bottles (NDC 64980-514-05), from lots 083H009 (Exp. 7/25), 083J022 (Exp. 9/25), and 083L046 (Exp. 11/25). The product was manufactured by FDC Limited, Waluj, Aurangabad, Maharashtra, India, and distributed by New Jersey-based Rising Pharmaceuticals throughout the United States.

FDC Limited voluntarily initiated the recall on July 18, 2024. On August 13, 2024, the FDA designated it Class II, signaling that use of the affected product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

FDC Limited initiated a similar recall for timolol maleate ophthalmic solution on April 25, 2024.

Timolol maleate ophthalmic solution is a prescription drug indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.