Recalling firm
FDC Limited
Product type
Drug
Status
Ongoing
Report date
2024-08-28
Distribution
Nationwide U.S.A.
Product quantity
176,784 bottles
Initiated by
Voluntary: Firm initiated
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.
Product description
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
Code / lot info
Lot #: a) 083K063, Exp 10/31/2025; b) 083I091, Exp 08/31/2025.
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.