Recalling firm
FDC Limited
Product type
Drug
Status
Terminated
Report date
2024-05-15
Distribution
New Jersey Only
Firm state
N/A
Product quantity
382,104 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Product description
Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ
Code / lot info
Lot #: a) 083H008, Exp. Date 07/2025; 083G003, Exp. Date 06/2025; 083J017, Exp. Date 09/2025; b) 083I013, Exp. Date 08/2025.
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.