Drug Enforcement D-0114-2025

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.

Status

Ongoing

Classification

Class II

Report Date

December 18, 2024

Termination Date

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Product Information

Product description
Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15.
Product quantity
5184 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 initiation reason
—
Initial firm notification
Letter
Distribution pattern
Distributed to one Us Distributor in NJ.

Location & Firm

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

India
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0114-2025
Event ID
95921
Recall initiation date
December 5, 2024
Center classification date
December 6, 2024
Code info
Lot #: 083I006, Exp 08/31/2025
More code info
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