Class II
Completed
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
- Company
- Fdc Limited
- Recall Initiated
- April 25, 2024
- Posted
- May 15, 2024
- Recall Number
- D-0488-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 382,104 units
- Firm Location
- Aurangabad, Maharashtra State, India
Reason for Recall
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Distribution
New Jersey Only
Lot / Code Info
Lot #: a) 083H008, Exp. Date 07/2025; 083G003, Exp. Date 06/2025; 083J017, Exp. Date 09/2025; b) 083I013, Exp. Date 08/2025.
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