Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), an...
FDA Recall #D-0488-2024 — Class II — April 25, 2024
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
Reason for Recall
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Recalling Firm
FDC Limited — Aurangabad, Maharashtra State, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
382,104 units
Distribution
New Jersey Only
Code Information
Lot #: a) 083H008, Exp. Date 07/2025; 083G003, Exp. Date 06/2025; 083J017, Exp. Date 09/2025; b) 083I013, Exp. Date 08/2025.
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated