Class II
Ongoing
Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15.
- Company
- Fdc Limited
- Recall Initiated
- December 5, 2024
- Posted
- December 18, 2024
- Recall Number
- D-0114-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5184 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
Distributed to one Us Distributor in NJ.
Lot / Code Info
Lot #: 083I006, Exp 08/31/2025
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