FDC Limited
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A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
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
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. 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. Open the enforcement explorer →