FDAHealthJuly 5, 2025
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: spike of the cap becomes lodged in the nozzle of the product bottle.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 5, 2025
U.S Nationwide.
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.
- Brand
- TIMOLOL MALEATE
- UPC
- 0364980513050
- Lot code
- 083L061
Additional details
Lot#: 083L061, Exp.: 11/2025.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 154,176 bottles.
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