Ophthalmic Solution Recalled

Akorn Inc is recalling a single lot of timolol maleate ophthalmic solution after detecting a timolol phenol S-oxide impurity during 12-month stability testing. The recall was included in the September 7, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects timolol maleate ophthalmic solution 0.5%, 5 x 0.3-mL single-dose vials (NDC 17478-189-24), from lot 9N72 (Exp. 9/30/22). The solution was manufactured for Akorn Inc, Lake Forest, IL, and was distributed throughout the United States.  

Akorn voluntarily initiated the recall August 8, 2022. On August 29, 2022, the FDA designated the recall Class III, suggesting use of the recalled product is not likely to cause harm.

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