Defective Containers Prompt Eye Drop Recall

Reports of defective containers have prompted FDC Limited to recall 4 lots of timolol maleate ophthalmic solution distributed in New Jersey. According to the May 15, 2024, US Food and Drug Administration (FDA) Enforcement Report, several customers have reported a yellow spike from the cap lodged in the nozzle.

The recall affects the following products, which were manufactured by FDC Limited, Maharashtra, India, and distributed in New Jersey by Rising Pharmaceuticals Inc.:

• timolol maleate ophthalmic solution, 0.5%, packaged in 5-mL bottles (NDC 64980-514-05), from lots 083H008 (Exp. 7/25), 083G003 (Exp. 6/25), and 083J017 (Exp. 9/25); and
• timolol maleate ophthalmic solution, 0.5%, packaged in 15-mL bottles (NDC 64980-514-15), from lot 083I013 (Exp. 8/25).

FDC Limited voluntarily initiated the recall on April 25, 2024. The FDA designated the recall Class II on May 7, 2024. Per the classification, use of the product may cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.

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.