WhichRecall
Class IIReported 2025-08-06

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.

Recalled by FDC Limited

Reason for Recall

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

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Recall Number
D-0543-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-07-05
Reported
2025-08-06
Distribution
U.S Nationwide.
Code Info
Lot#: 083L061, Exp.: 11/2025.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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