Class II
Ongoing
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
- Company
- Fdc Limited
- Recall Initiated
- July 5, 2025
- Posted
- August 6, 2025
- Recall Number
- D-0543-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 154,176 bottles
- Firm Location
- Aurangabad, Maharashtra State, India
Reason for Recall
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Distribution
U.S Nationwide.
Lot / Code Info
Lot#: 083L061, Exp.: 11/2025.
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Feb 12, 2025 · Class II
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