FDA Recall D-0403-2025

FDC Limited · Aurangabad, Maharashtra State, N/A

Class II Ongoing 391 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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.

Lot / code: Lot #: 083I098, Exp. Date 08/31/2025

Quantity: 60428 bottles

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.

Recall record

Recall number: D-0403-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S. Nationwide
Recall initiated: 2025-04-18
Classified by FDA Center: 2025-05-05
FDA published: 2025-05-14
Recalling firm: FDC Limited
Firm location: Aurangabad, Maharashtra State, N/A, India

Drug identification

Brand name(s): TIMOLOL MALEATE
Generic name(s): TIMOLOL MALEATE
Manufacturer(s): Rising Pharma Holdings, Inc.
NDC(s): 64980-513, 64980-514
Route(s): OPHTHALMIC

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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