FDA Recall D-0632-2024

FDC Limited

Class II Ongoing 665 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, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, [NDC 64980-514-05].

Lot / code: Lot Number: 083J022, Expiration Date: September- 25; 083L046, Expiration date: November- 25; 083H009, Expiration date: July- 25

Quantity: 362,544 bottles

Reason for recall

Defective container; yellow colored spike from cap lodged in the nozzle

Recall record

Recall number: D-0632-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the US
Recall initiated: 2024-07-18
Classified by FDA Center: 2024-08-13
FDA published: 2024-08-21
Recalling firm: FDC Limited

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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