Recalling firm
FDC Limited
Product type
Drug
Status
Ongoing
Report date
2025-05-14
Distribution
U.S. Nationwide
Firm state
N/A
Product quantity
60428 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall
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 description
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01.
Code / lot info
Lot #: 083I098, Exp. Date 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.