Drug Recall: 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, Di
FDC Limited · August 12, 2024
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
Distribution
Nationwide U.S.A.
States Affected
NATIONWIDE
Quantity Affected
176,784 bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0642-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.