FDC Limited recalls Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Auran
Recalled August 21, 2024 · FDA recall D-0632-2024 · FDC
Hazard
Defective container; yellow colored spike from cap lodged in the nozzle · FDA Class II
Units
362,544 bottles
Sold at
Nationwide in the US
Description
Defective container; yellow colored spike from cap lodged in the nozzle
Product
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, [NDC 64980-514-05].
Manufacturer(s)
FDC Limited
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →