Class II
Ongoing
Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey
This recall is currently active, issued August 28, 2024. It was issued by Fdc Limited.
- Company
- Fdc Limited
- Recall Initiated
- August 12, 2024
- Posted
- August 28, 2024
- Recall Number
- D-0642-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 176,784 bottles
- Firm Location
- Aurangabad, Maharashtra State, India
- Official Source
- View on FDA website ↗
Reason for Recall
Defective Container: patients are 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
Nationwide U.S.A.
Lot / Code Info
Lot #: a) 083K063, Exp 10/31/2025; b) 083I091, Exp 08/31/2025.
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