FDAHealthApril 18, 2025
FDC Limited — Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL 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
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 18, 2025
U.S. Nationwide
What's affected?
- Product
- Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01.
- Brand
- TIMOLOL MALEATE
- UPC
- 0364980513050
- Lot code
- 083I098
Additional details
Lot #: 083I098, Exp. Date 08/31/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 60428 bottles.
Get Health recall alerts
Delivered to your inbox. Free. No account required.