Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey

FDA recall notice · announced August 28, 2024 · Fdc Limited

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey

Reason for recall

Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Notes

Distribution: Nationwide U.S.A.
Lot/code information: Lot #: a) 083K063, Exp 10/31/2025; b) 083I091, Exp 08/31/2025.
Quantity: 176,784 bottles
Status: Ongoing
Products in this recall event:
- Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Di (D-0642-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.