Recalling firm
FDC Limited
Product type
Drug
Status
Ongoing
Report date
2024-11-13
Distribution
Distributed to one Us Distributor in NJ.
Firm state
N/A
Product quantity
155,232 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, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
Code / lot info
Lot #: 083L051, Exp. Date: 11/2025
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.