Glaucoma Medication Recalled

Apotex Corp is recalling 22,027 bottles of timolol maleate ophthalmic solution because samples of the drug failed to meet stability specifications. According to the January 4, 2023, US Food and Drug Administration (FDA) Enforcement Report, samples were “out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.”

The recall affects timolol maleate ophthalmic solution 0.5%, 2.5 mL (NDC 60505-1005-4), from lot TA4844 (Exp. 3/23). The solution was manufactured by Apotex Inc, Toronto, Ontario, Canada, for Apotex Corp, Weston, Florida, and distributed throughout the United States.

Apotex Corp voluntarily initiated the recall December 21, 2022. On December 28, 2022, the FDA designated the recall Class III, suggesting use of the recalled solution is not likely to cause harm.

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