Recall
FDAHealthOctober 29, 2024

FDC Limited — Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals

⚠️ 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

Is this relevant to me?

Geography
NJ
Source agency
FDA
Category
Health
Published
October 29, 2024

Distributed to one Us Distributor in NJ.

What's affected?

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.
UPC
0364980513050
Lot code
083L051

Additional details

Lot #: 083L051, Exp. Date: 11/2025

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 155,232 bottles.

View original FDA notice →

Get Health recall alerts

Delivered to your inbox. Free. No account required.