Class II
Ongoing
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01.
- Company
- Fdc Limited
- Recall Initiated
- April 18, 2025
- Posted
- May 14, 2025
- Recall Number
- D-0403-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 60428 bottles
- Firm Location
- Aurangabad, Maharashtra State, India
Reason for Recall
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Distribution
U.S. Nationwide
Lot / Code Info
Lot #: 083I098, Exp. Date 08/31/2025
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