Drug Enforcement D-0543-2025

Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.

Status

Ongoing

Classification

Class II

Report Date

August 6, 2025

Termination Date

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Product Information

Product description
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.
Product quantity
154,176 bottles
Reason for recall
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
U.S Nationwide.

Location & Firm

Recalling firm
FDC Limited
Address
B-8 MIDC Industrial Area, Waluj District

India
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0543-2025
Event ID
97219
Recall initiation date
July 5, 2025
Center classification date
July 29, 2025
Code info
Lot#: 083L061, Exp.: 11/2025.
More code info
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