FDC Limited recalls Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aur
Recalled December 18, 2024 · FDA recall D-0114-2025 · FDC
Hazard
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. · FDA Class II
Units
5184 bottles
Sold at
Distributed to one Us Distributor in NJ.
Description
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Product
Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15.
Manufacturer(s)
FDC Limited
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →