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
- October 29, 2024
- Posted
- November 13, 2024
- Recall Number
- D-0035-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 155,232 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 #: 083L051, Exp. Date: 11/2025
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