Drug Enforcement D-0035-2025

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

November 13, 2024

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
155,232 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
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Codes & Dates

Recall number
D-0035-2025
Event ID
95648
Recall initiation date
October 29, 2024
Center classification date
November 1, 2024
Code info
Lot #: 083L051, Exp. Date: 11/2025
More code info
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